18 Inspection Manager jobs in Egypt

**Purpose**:
Regulatory Affairs Supervisor is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations.

**Responsibilities**:

- Secure obtaining marketing authorizations of new launches in line with the company’s plans and goals.
- Secure the submission and approval of renewals for products portfolio on timely manner to maintain licenses for existing products.
- Secure the submission and approval of variations for products portfolio on timely manner.
- Ensure preparation of submission documents for new product registrations, renewals, and variations.
- Ensure preparation of responses to requests by the Authority during the evaluation process, and timely handle deficiency letters within a specific timeframe.
- Ensure implementation of the regulatory plans in a timely and accurate manner.
- Create and maintain a full up-to-date database and archiving system for tracking Regulatory dossiers.
- Ensure effective communication with the Regulatory Authority.
- Ensure company compliance to regulatory regulations.
- Follow up and implement any updates on the regulatory regulations and guidelines, keeping all relevant stakeholders timely and pro-actively updated.
- Effective communication and cross-functional interaction with all involved departments, both on a Regional and Central level (Regulatory Affairs, Quality Assurance, Quality Control, Production, Supply chain, Sales and Marketing and Pharmacovigilance) to facilitate and develop effective collaboration on all regulatory interactions.

**Qualifications**:

- Bachelor degree in Pharmacy.
- At least 6-8 years professional experience in Regulatory Affairs.
- Good understanding of Regulations.
- Knowledge of the structure and the specifics of formation and functioning of the dossier in CTD/eCTD formats.
- High English proficiency.

As a Regulatory Affairs Executive, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities.

**Responsibilities**
- Ensuring compliance with all regulatory requirements
- Preparation and submission of all regulatory reports
- Providing accurate reviews of data and reports
- Ensuring accurate and timely submissions to regulatory agencies
- Advising others on regulatory and compliance matters
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in changes.
- Identify relevant guidance documents, international standards, or consensus standards.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Compile and maintain regulatory documentation databases or systems.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

**Qualifications**
- Bachelor’s degree in a scientific field such as Pharmacy
- Two years of experience in a similar role
- Excellent verbal and written communication skills
- Strong interpersonal skills
- Excellent customer service skills
- Strong problem-solving skills
- Excellent organizational skills
- Highly developed attention to detail
- Strong project management skills
- Ability to work well in a team environment

We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.
This role reports to the Regulatory Affairs Manager and is based in Egypt or Tunisia.
**Scope of Work**
+ Egypt, Libya, Jordan, and GCC regulatory experience is required.
+ Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.
+ Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.
+ Experience with reliance regulations in Egypt and the GCC is essential.
**Responsibilities**
+ Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.
+ Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.
+ Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.
+ Possess good knowledge of pharmacovigilance requirements in relevant countries.
+ Engage with health authority officials as needed and represent the client.
+ Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.
+ Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.
+ Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.
+ Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.
+ Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.
+ Perform other tasks or assignments as delegated by Regulatory Management.
**Qualifications**
+ Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.
+ High proficiency in English and Arabic is essential; French proficiency is a plus.
+ At least 3-5 years of relevant regulatory experience in a national or regional scope of work.
+ Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.
+ Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.
+ Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.
+ Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.
+ Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.
+ Knowledge of pharmaceutical industry operations.
+ Strong interpersonal communication and organizational skills.
+ Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
+ Demonstrates self-motivation, enthusiasm, and a high sense of ownership.
+ Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Essential Functions
- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
- Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
- May prepare and deliver regulatory training to IQVIA small groups or individuals;
- Performs other tasks or assignments, as delegated by Regulatory management;

**Qualifications**:

- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's Degree Degree in Lifescience or related discipline Req
- At least 3-4 years relevant experience
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
- Possesses a specific regulatory or technical expertise;
- Good, solid interpersonal communication (oral and written) and organisation skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Ability to adapt quickly to a rapidly changing environment;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

LI-Remote

LI-KIMBERLYODONOGHUE

**MultiCare **Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions.

**MultiCare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics, and medical devices. MultiCare has +22 years of prominent existence in the local market and has almost +69 products marketed and more to come through the pipelines. **MultiCare** Egypt for Pharmaceutical Industries is the manufacturing facility which located at the Industrial Zone - New Cairo and its HQ is close by the facility as well in New Cairo. We are one of the fast-growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.

Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India, and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).

**Vacancy**:

- **Designation**: Regulatory Affairs Supervisor
- **Location**: Industrial Zone, third Settlement, New Cairo
- **Grade**: RA01/RA02
- **Reporting**:Regulatory Affairs Manager

**Job Purpose**:
We are seeking a Regulatory Affairs Manager to provide support as we expand our product line. In this role, your primary responsibility is to oversee regulatory submissions, ensuring they are compliant with prevailing regulations as well as the guidelines set by other relevant regulatory bodies. You will also assist with external audits and respond to any complaint documentation regarding Multicare's portfolio

**A. Essential Duties and Responsibilities**:

- Contribute to the formulation and execution of regulatory strategies for Multicare's portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
- Act as one of the RA advisors on the applicable regulations that govern products in remit, provide guidance and considering all possible interpretations and regulatory pathway
- Provide Regulatory Affairs program governance, administration, business attestation review, metrics/reporting, and training
- Manage, maintain and communicate relevant policies, standards and procedures
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Provide support for all external audits Accountability, including audit corrective and preventive action plans (CAPAs).
- Collect, collate and evaluate scientific data from a range of sources
- Prepare submissions of license variations and renewals to strict deadlines
- Project manage teams of colleagues involved with the development of new products
- Negotiate with regulatory authorities for marketing authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release
- Act as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products
- Examine the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Enhance existing engagement model and serve as a trusted business partner representing the Regulatory Affairs organization to business functions, business lines, and other stakeholders
- Act as internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action

**B.Qualification/Knowledge/Experience**:

- **Level of education**: Life Science Degree (Pharmacy, Veterinary or Science)
- **Experience**: ≥ 3-5 years work experience in Regulatory Affairs function within pharmaceutical sector
- **Language**:English proficiency is mandated
- **IT Literacy**: Professional MS-Office knowledge

**C.Competencies and Behaviors**:

- Professional networking and MoH access
- Ability to work under sustainable pressure and handling of simultaneous tasks to meet timeline
- Strong planning and organization capabilities
- Ability to influence, convince and persuade
- Strong sense of accountability and autonomy
- Negotiation skills
- Must be flexible a

**Job Description**:
**Are You Ready to Make It Happen at Mondelēz International?**

**Join our Mission to Lead the Future of Snacking. Make It With Pride.**

You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs and requirements of our portfolio carried out.

**How you will contribute**

You will deliver on the regulatory affairs strategy and compliance agenda and work with cross-functional stakeholders to assess regulatory business risks and opportunities. You will provide regulatory affairs expertise for technical regulatory developments and help in responses to challenges and crisis management. In this role, you will ensure that ingredients, product composition, claims and labelling compliance are within applicable regulations and company policies. In addition, you will provide guidance to stakeholders on developments in regulatory affairs, support regulatory impact assessments and change management, help develop regulatory affairs tools, and further develop your knowledge of regulatory, science and nutrition risks and opportunities in your market.

**What you will bring**

A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:

- Networking and communication skills
- Reliability and accuracy and an efficient work style
- Meeting deadlines
- Attending to detail
- Project management
- Regulatory affairs in an international and multi-functional environment

**More about this role**

**What you need to know about this position**:
In this role you will ensure that ingredients, product composition, claims and labelling of the products in MDLZ portfolio are compliant with applicable regulations and company policies. You will be responsible to validate raw materials, recipes, prepare the labelling information (legal designation, ingredient line, nutrition information, etc.) and validate packaging/artworks prior to the printing. In your role you will help in responses to challenges and issue management. In addition, you will provide regulatory guidance to stakeholders on the projects, and further utilize your knowledge of regulatory, science and nutrition and create opportunities in.

**What extra ingredients you will bring**:
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:

- Networking and communication skills
- Reliability and accuracy and an efficient work style
- Meeting deadlines
- Attending to detail
- Project management
- Regulatory affairs in an international and multi-functional environment

You will be part of an enthusiast and committed Regulatory team - located in various countries - Together we make it happen!

**Education / Certifications**:

- Bachelor's Degree in Food S ciences, Pharmacy or Biotechnology
- Master's degree is a plus

**Job specific requirements**:

- Minimum 1-3 years of experience French Speaker is a plus

**Work schedule: Full time**

**No Relocation support available**:
**Business Unit Summary**:
**Mondelēz International in the Middle East, North Africa and Pakistan serves the Middle East and Africa markets as well as Australia, New Zealand, the UK and Canada. Headquartered in Dubai, UAE, we have more than 2600 employees working across seven plants and six commercial offices; we make, bake, sell and deliver our products to customers. We are market leaders in key snacking categories with iconic global and local brands including Cadbury Dairy Milk chocolate, Milka, Oreo and belVita biscuits, Barni Cakes,Tang powdered beverage, Chiclets and Trident gum and Halls candy.**:
Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.

**Job Type**:
Regular

Scientific Affairs & Regulatory Affairs

Product Quality, Safety and Compliance

The Role

Overview

A leading pharmaceutical company is actively recruiting a Senior Regulatory Affairs Specialist for their Cairo office.

Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.

Responsibilities

• Maintenance of assigned, authorized products through timely submission of variations and renewal applications.
• Track and follow up with the submission of regulatory files (renewals, variations, etc.).
• Oversee post-marketing activities, including reporting adverse events and product quality complaints.
• Build and maintain strong relationships with regulatory bodies across the region.
• Prepare and review regulatory documents for accuracy and completeness.
• Work closely with R&D, quality assurance, supply chain, marketing, and legal departments to align regulatory strategies.
• Monitor and analyse regulatory trends in the MENA region.

Ideal Candidate Profile

• Only candidates currently based in Egypt will be considered.
• Bachelor's degree in Pharmacy, Life Sciences, or related field. An advanced degree (MBA, MSc) is a plus.
• Minimum 5 to 8 years of regulatory affairs experience within the pharmaceutical or healthcare industry.
• Experience in MENA-specific regulatory environments is a must.
• Strong understanding of regional and global regulatory standards.
• Detail-oriented with strong organizational and project management abilities.

Requirements About the company Flow Talent have been sourcing the best Banking, Technology, Financial Services & Legal professionals locally and internationally for leading organisations across the Middle East region since 2018. Through years of experience, we know there is significant demand for highly skilled professionals and pride ourselves on having the highest calibre candidates. As a team, we strive to help our clients achieve operational and business excellence by identifying quality talent, quickly, through our collaborative approach. Flow place professionals in the following sectors: - Banking & Financial Services - Digitalisation & Technology - Legal & Compliance We help our clients with: - Contingent Recruitment: - Retained Recruitment - Emiratization and Saudization - Market Entry

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

The Regulatory Affairs Senior Specialist in MEAR RA Hub is responsible for
- Defining and implementing regulatory strategies and submissions in support of new and existing product s. As well as Plans and manages all assigned regulatory activities accordance with implemented regulations in North Africa & other African markets.
- The timely response to Health Authorities' requests r elated to regulatory submissions.
- Timely completion of regulatory projects and submission of documentation to regulatory agencies.
- Ensure product labelling and advertising materials for all products comply with product dossiers and relevant regulations.
- Represents Regulatory Affairs on cross-functional project teams to support planning, development, implementation and execution of marketing strategies and ensures alignment with project business goals relating to combination product chemistry, manufacturing and controls (CMC) as well as product labeling issues on a local and global basis.
- Assist the Regional and Global Regulatory team in analyzing country product data, regulatory legislation and providing country specific information.
- Responsible for compliance with post-market approval regulatory obligations and maintenance of licenses/ authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact, and identification of Process Excellence improvements.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.

We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Job Requisition ID: 251750

Location: Cairo

Career Level: C - Professional (1-3 years)

Working time model: full-time

**North America Disclosure**

from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact from 8:00am to 5:30pm ET Monday through Friday, for assistance.

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

**Job Segment**:Developer, Neurology, Oncology, Technology, Healthcare

**HOW MIGHT YOU DEFY IMAGINATION?**
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Sr Associate Regulatory Affairs - based in Egypt**
**Live**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :
+ Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements
+ With close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicable
+ Reviews promotional and non-promotional materials
+ Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner
+ Partners with Regulatory Affairs Lead to support the regulatory development, registration, and lifecycle management of all Amgen molecules
+ Partners with peers to ensure consistency on procedures
+ Assists locally in Healthcare Compliance activities, where applicable
+ Participates in local regulatory process improvements, initiatives, and training
+ Establishes regular contacts and interactions with Distributors (if applicable).
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications.
**Basic Qualifications:**
+ Bachelor`s degree in Pharmaceutical Science
+ Knowledge of the Gulf legislation and regulations
+ Awareness of the registration procedures in region, post approval changes, extensions and renewals
+ Knowledge of Regulatory principles
+ Working with policies, procedures and SOP's
+ Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
+ Understanding of drug development
+ Demonstrate ability to work in teams
+ Ability to understand and communicate scientific/clinical information
**Preferred Qualifications:**
+ Degree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)
+ Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.
+ Experience interacting with regulatory agency in the Gulf markets
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.