14 Regulatory Affairs Specialist jobs in Egypt

**وصف الوظيفة**:
**Purpose of the job**:
**Primary Tasks**:

- Responsible for Pharmaceutical products, Dietary supplement, Medical Devices and cosmetics products in the following areas.
- Oversee the regulation process for products requiring governmental or international approvals.
- Update licensing and collects information on registration instructions and regulations.
- Obtain/generate information to be submitted to regulatory authorities and prepares required regulatory dossiers.
- Manage the final product submissions and negotiates and communicates effectively with regulatory authorities to obtain timely product approvals & pricing.
- Provide direct assistance with the registration of new and existing products in markets supplied by the plant.
- Assume regulatory review of labeling content, product and process changes and product documentation.
- Manage the distribution of new regulations, standards, policies, and guidelines issued by relevant regulatory authorities that may impact the company.
- Archive all related work documents soft and hard copies.
- Submit and follow up new registration, Re-registration, variation files for analysis till receiving conformity.
- Follow up batches and raw material samples submitted for analysis till receiving conformity.
- Maintains a high level of knowledge and skill on current matters concerned with the regulation and approval of medicinal products and devices.
- Undertaking and managing regulatory inspections.
- Perform any assigned duties related to DRA.

**المهارات**:
**Education, Skills, Experience required**:

- Bachelor’s degree in pharmaceutical science or science.
- Experience of Drafting Regulatory Files.
- Excellent English, verbal / written communication.
- Strong communication skills and networking.
- Ability to work well through others.
- Excellent computer skills.

**المؤهلات العلمية**:
Pharmaceutical science or science

**تفاصيل الوظيفة**:

- مكان الوظيفة- القاهرة, مصر- الدور الوظيفي- التصنيع- الحالة الوظيفية- دوام كامل- نوع التوظيف- موظف- عدد الوظائف الشاغرة- 1**المرشح المفضل**:

- المستوى المهني- مبتدئ الخبرة- عدد سنوات الخبرة- الحد الأدنى: 1 الحد الأقصى: 3- منطقة الإقامة- مصر- الجنسية- مصر- الشهادة- بكالوريوس

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

JOB PURPOSE:

- Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.

KEY RESPONSIBILITIES AND DUTIES:

- Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines.
- Timely implementation of all plans/projects with strict follow up with both internal & external stakeholders for timely achievement of the plans/projects.
- Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling review and approval with respect to internal KPIs.
- Updating internal Sanofi systems regularly and on time following internal KPIs.
- Revision and approval of promotional materials and any updated packaging materials on artwork system.
- Following and complying with all defined internal policies and procedures of working.
- Following strictly all the Authority Regulations, decisions & decrees.
- Carry out all communication and follow up required with local affiliate, region and corporate as appropriate.
- Work in collaboration with internal and external stakeholders to manage issues that might lead to supply impact.
- Familiar with all regulations to support day to day activities.
- Respect quality and compliance aspects.

JOB-HOLDER’s ENTRY REQUIREMENTS_:_

**Education**:

- Pharmacist, Physician, Veterinarian

Related Experience:

- 1-3 years of regulatory affairs experience, preferably in multinational organization

Special Knowledge/Skills:

- High level of communication skills and ability to influence other.
- Organization skills and high accuracy in documentation
- High sense of urgency
- Priority setting and management
- Knowledge of new decrees & guidelines
- Multitasker
- Promptness in respond to authorities’ requirements and prompt in deliverables
- Analytical skills
- Ability to alert hierarchy in case of specific situation impacting his/her work environment
- Problem solving skills
- An understanding and appreciation of relevant legal, scientific and manufacturing area

PTW Behaviors:

- Stretch to go beyond the level we have operated at up until now.
- Take action instead of waiting to be told what to do.
- Act in the interest of our patients & customers.
- Put the interests of the organization ahead of my own or those of our team.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

**Position Summary**:
In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping healthcare in the region. This polyvalent role offers strong collaboration between different groups across the company.

**Main responsibilities**:
**In charge of the Regulatory Affairs **Process **& **Compliance activities**:

- Stay up to date with evolving regulations and standards in the Pharma sector in the NEMA region and ensure that J&J remains in compliance.
- Prepare for and assist during regulatory audits and inspections, providing accurate and comprehensive information.
- Collaborate with the Commercial Quality team to maintain and improve quality management systems and procedures.
- Work closely with functions that might have interdependencies with Regulatory Affairs (e.g. Pharmacovigilance, Quality, Supply Chain, Labeling.) to improve collaboration and outcomes/deliverables
- Assist in product registrations, submissions, and approvals, ensuring timely compliance with regulatory requirements and J&J’s procedures.
- Conduct risk assessments and develop strategies to mitigate regulatory risks and issues.
- Ensure efficient implementation and maintenance of the key RA processes and corresponding systems, including but not limited to Change controls, local deviations, CAPAs, records management, and archiving. Planning & tracking, information sharing, and Regulatory Intelligence.
- Provide regulatory process support for Regulatory Experts to ensure they recognize procedures they should adhere to.
- Write and review Job Aids, Work Instructions, and SOPs in accordance with the applicable responsibilities' scope.

**QUALIFICATIONS**:
**Job Requirements**:
**Qualification & Experience**:

- Scientific Degree or equivalent experience, within Pharmaceutical or Biomedical Science.
- proven experience (5+ years) in RA Compliance, Regulatory Affairs, and Quality

**Knowledge & Skills**:

- Proficiency in English and Arabic, and knowledge of French is preferred
- Project Management experience
- Experience in the use of a selection of the following technologies: Information systems based on database technology or Web/Internet technology, document management systems
- Cross-Functional work

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

A leading **Medical Device** company is actively recruiting a **Regulatory Affairs and Quality Assurance Specialist for** their **Egypt** office.

**The main responsibilities will include but not limited to**:

- Enhance and develop regulatory compliance of management system.
- Define and execute regulatory plans and manage timelines to achieve the stated goals.
- Responsible for regulatory reports, routine reports, permits, approvals, and maintenance of regulatory licenses.
- Responsible for the preparation of regulatory submissions and applicable documentation.
- Coordinate and facilitate quality risk management and product development.
- Ensure marketing materials and product information are according to regulations and policies.
- Coordinate with suppliers to resolve quality and compliance issues.
- Performs investigation of quality complaints, accidents, and incidents to determine causes and preventive measures.
- Facilitate design and process validations, release testing, and sterilization inspection activities.
- Updated on relevant regulations, guidelines, and standards.

**To be successful you will need to meet the following**:

- **Bachelor’s degree.** Preferably in a scientific discipline such as Science, Engineering, or similar. Regulatory Affairs Certification (RAC) is a plus.
- **Minimum 3 - 5 years relevant experience within the Medical Devices Industry.**:

- Good Knowledge of QA and RA requirements, compliance regulations, and industry practices.
- **Excellent verbal and written English**.** Arabic is an advantage.
- Motivated, proactive, dynamic, methodical, organised, and decisive.
- Applicants should be available for face-to-face interviews in the location mentioned above.

**_Are you on Instagram? _**_Follow us_**_ to make sure you to stay up to date with the latest industry news, vacancies and more!_

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Come and join our regional Regulatory Affairs Team as Regulatory Affairs Manager to oversee both pre-market and post-market regulatory activities in Levant, Gulf and Pakistan countries (Cyprus, Iran, Iraq, Jordan, Lebanon, Syria, Bahrain, Kuwait, Oman, Qatar, Yemen, UAE, Pakistan and Afghanistan) and work with a talented team.
The role is crucial to enable timely product launches and business continuity in the said regions by sustaining strong relations with distributors, authorities as well as internal stakeholders including country leaders. The role will report into Sr. Regulatory Affairs Manager responsible for Turkiye, West Asia, Levant and Gulf.
**Responsibilities may include the following and other duties may be assigned:**
+ Drives an effective product planning & submission process across region with proactive alignment with relevant stakeholders
+ Leads to compile all materials required in submissions, license renewal and annual registrations
+ Recommends changes for labelling, manufacturing, marketing for regulatory compliance
+ Ensure audit readiness in organization and continue meeting our Quality KPIs
+ Ensures effective monitoring, communication and collaboration on new & changing regulations and required actions
+ Executes a comprehensive Q/RA advocacy strategy and may direct interaction with regulatory agencies on defined matters. Active participation in related Trade Associations
+ Recommends strategies for earliest possible approvals of product dossiers in specified regions and drive optimization and foster innovation in regulatory processes
+ Foster and contribute to the culture of Engagement, Inclusion and Innovation as a people manager.
**Required Knowledge and Experience:**
+ Bachelor's degree or equivalent
+ Minimum 5 years of experience in the regulatory affairs
+ Strong leadership skills including proven minimum 1 year of people management
+ Ability to influence to authorities and stakeholders & strong presentation skills
+ Strong communication skills
+ Proven success stories in Regulatory Affairs & Quality Assurance
+ Medical device experience and knowledge in those countries are preferred
+ Strong adoption skills and ability of multi-tasking
+ Strong follow-up skills with being result-oriented
+ Excellent fluency in English both written and verbal.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
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About the job Director, Regulatory Affairs

**Purpose of the job**

Managing the regulatory affairs, overseeing the industry practices & ensure all government regulations being met to support the current and future strategic plans of Orange.

**Duties and responsibilities**
- Ensure coordination and enrichment of the company's strategic plan.
- Provide regular analysis on the operation/ strategic projects and support on decision making.
- Support all business stake holders on Sales & Marketing plan and pricing in addition to resolving ongoing issues affecting customers and enterprises.
- Lead all regulatory and compliance related matters including policies, audit, and any other guidelines related to regulatory bodies.
- Ensure constant improvements & enhancement in existing products & processes to streamline operations, and resolve consumers, sales.
- Manage & ensures seamless operational support.
- Actively manage team members & oversees department operations on a day-to-day basis, measuring operational performance towards achieving vertical goals, through coaching, fostering positive work culture & constructive feedback.
- Represent Orange Egypt in front of different governmental authorities related to regulatory issues.
- Support Executive Committee in all regulatory affairs matters.
- Ensure providing full support for Orange shareholders with the data and information they require.
- Represent Orange Egypt in all meetings & negotiations with NTRA, other operators, Ministry of Telecom and other Governmental bodies.
- Responsible for financial rights and obligations driven by the regulatory activities.
- Attend all commercial/Financial meetings/conferences that require the presence of the Regulatory.
- Negotiate and formulize new licenses, process, and agreements.
- Represent Orange Egypt in front of the governmental authorities.
- Make sure that clear and consistent processes are in place.
- Develop and execute the company regulatory strategy in a wide range of issues to minimize the adverse financial and business impact of specific sector regulation and to maximize the future business growth opportunities.
- Assess risks and opportunities in existing regulatory framework, developing risk mitigation actions and creating policy recommendations for opportunity areas.
- Govern business units to secure procedures are up-to-date and meet latest regulatory requirements.
- Develop strong arguments for building new regulations regarding the next generation telecommunication services and products.
- Analyze impacts of new technologies and preparing Oranges regulatory position accordingly.
- Ensure local approvals from the different local authorities are obtained on time.
- Manage the needed process are being developed and met.
- Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Establish strong communication channels with the top officials and decision makers in Telecom Egypt & the Regulator for the best interest of the business.

**People Management**
- Interview and select direct reports and validate hiring decisions for the department.
- Provide coaching and request needed training for direct reports ensuring continuous individual development.
- Ensure a healthy working environment for the department employees through focusing on team building and motivation initiatives.
- Conduct regular performance and competency evaluations for direct reports while delivering constant constructive feedback for higher achievements and further development.

**Job specification**

**Education**
- University degree from a recognized university.
- Post graduate studies in Regulatory and Public Affairs field are an asset.

**Experience**
- Minimum 20 years of experience in Regulatory Affairs, 10 of which in an upper management role.
- Background in Telecom Industry is an asset.
- Strong relationship with government and telecom authorities.

**Skills and abilities**
- Very good English both spoken and written.
- Very good computer skills.
- Strong planning and controlling skills.
- Strong people management and leadership skills.
- Strong communications and interpersonal skills.
- Strong analytical thinking and decision making skills.

**Labeling and packaging activities management for Middle East North African region for Amgen portfolio**
- Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region
- Ensure delivery of right first time label source text for artwork creation
- Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
- Access the translation systems to request the label translation and track the job readiness and timelines.
- Perform regional prescribing information translation review: 100% review of both content and format
- Perform the role of source text owner/approver and artwork reviewer/approver in the system with end to end labeling process ownership
- Trigger the existing label revision when alerted by global RA team and support planning.
- Support in making product ready for supply by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
- support launching new products in the MEA region.
- **Coordination and execution of Regulatory Affairs processes and deliverables in the local office**
- Disseminate relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Local SOPs redaction for labeling management.
- **Track and trace intelligence gathering and execution**
- GS1 knowledge and execution of the track and trace as per country requirements in the MEA region
- aggregation and master data management of Amgen products supplied across MEA region.

**Job Requirements**:

- Pharmacist, biologist, chemist-medical background
- 2-3 years’ experience in a similar role
- Fluent in English, Arabic and preferred French for translation review purpose
- A minimum knowledge of Middle East Africa regulatory requirements
- Hard worker, fast learner, positive attitude, team spirit, willing to take on challenges, details oriented.
- Strong communication skills both oral and written, with ability to understand and communicate the scientific information and anticipate/prevent potential issues
- Cultural awareness and sensitivity with ability to resolve conflicts and develop course of action.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

**Labeling and packaging activities management for Middle East North African region for Amgen portfolio**
- Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region
- Ensure delivery of right first time label source text for artwork creation
- Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
- Access the translation systems to request the label translation and track the job readiness and timelines.
- Perform regional prescribing information translation review: 100% review of both content and format
- Perform the role of source text owner/approver and artwork reviewer/approver in the system with end to end labeling process ownership
- Trigger the existing label revision when alerted by global RA team and support planning.
- Support in making product ready for supply by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
- support launching new products in the MEA region.
- **Coordination and execution of Regulatory Affairs processes and deliverables in the local office**
- Disseminate relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Local SOPs redaction for labeling management.
- **Track and trace intelligence gathering and execution**
- GS1 knowledge and execution of the track and trace as per country requirements in the MEA region
- aggregation and master data management of Amgen products supplied across MEA region.

**Job Requirements**:

- Pharmacist, biologist, chemist-medical background
- 2-3 years’ experience in a similar role
- Fluent in English, Arabic and preferred French for translation review purpose
- A minimum knowledge of Middle East Africa regulatory requirements
- Hard worker, fast learner, positive attitude, team spirit, willing to take on challenges, details oriented.
- Strong communication skills both oral and written, with ability to understand and communicate the scientific information and anticipate/prevent potential issues
- Cultural awareness and sensitivity with ability to resolve conflicts and develop course of action.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.