67 Regulatory Affairs jobs in Egypt

Country: Egypt

City: New Cairo

Job Family: Quality Regulations Expertise

Contract Type: Limited-term

Job ID: 52779

Regulatory Affairs Specialist

The Bel Group is a major player in the food industry through portions of dairy, fruit and plant-based products, and one of the world leaders in branded cheeses. Its portfolio of differentiated and internationally recognized brands includes The Laughing Cow, Kiri, Babybel, Boursin Nurishh, Pom'Potes and GoGo squeeZ, as well as some 30 local brands. Together, these brands helped the Group generate sales of €3.74 billion in 2024.

Do you want to join a company with strong brands that puts consumers and responsibility at the heart of the decision-making process? Then Bel is made for you

Are you bold, pragmatic, and determined? Do you want to contribute to the transformation of an international agri-food company? Them come join us and measure the impact of your talent and energy in realizing an ambitious and sustainable company project

#IWorkForAllForGood
Main Accountabilities:

• Ensure conformity with food regulations: Monitor, interpret, and apply NEAR market food regulations to product developments, ensuring compliance with local and Group requirements.
• Guarantee loyalty towards our consumers: Validate labelling, marketing, and promotional materials to ensure accuracy, transparency, and regulatory compliance.
• Act as the Regulatory Point of Contact for NEAR: Handle internal and external regulatory inquiries, providing accurate, timely guidance to stakeholders.
• Support Regulatory Operations and Reporting: Support in product registrations, maintain regulatory databases, and ensure readiness for internal and external audits.
• Collaborate Cross-Functionally to Enable Business: Partner with Marketing, R&D, Quality, Sales and Supply Chain to align regulatory activities with business priorities and timelines

Qualifications:

• Bachelor of Sciences, Pharmacy or Biotechnology
• 1-2 years of experience in Regulatory Affairs

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Company Description

Pharmacon is a German-Egyptian pharmaceutical company dedicated to promoting high-quality products in the Egyptian market. Founded in 2004, Pharmacon aims to improve the health of Egyptian patients by providing alternative medical solutions and addressing gaps in the market. We serve a diversified range of therapeutic areas with products sourced from high-standard European suppliers. Our mission is to improve the quality of life by offering affordable, high-quality pharmaceutical solutions and working with partners to achieve our goals. We aim to be a leading pharmaceutical company in the Egyptian market.

Rules & Responsibilities:

• Prepare, review, submit and receive regulatory documentation (e.g., CTD and eCTD submissions) and approvals; ensure follow-through on post-approval commitments.

• Coordinate with licensor regulatory teams to ensure alignment on country regulatory activities.

• Ensure compliance of product labeling, packaging, with local regulations and internal policies. Prepare, submit, follow up the importation plans and custom medical release for human and biological pharmaceuticals and medical devices.

• Prepare and submit lot release documentation as required by drug authority and liaise with the National Control Laboratory for additional testing where applicable.

• Follow up and attend the inspections of imported shipments.

• Prepare, submit and follow up documentations for laboratory testing at EDA labs.

Qualifications:

Bachelor's degree in Pharmacy.

Minimum of 2 years of experience in a similar position specially for imported products.

Fluency in English, both written and verbal are a must.

Strong personality, organizational skills and ability to plan and manage own work agenda independently.

Good understanding of regulations and related guidelines in the Gulf, Egypt for pharmaceutical and biological regulations; medical device knowledge is a plus.

Familiarity with different regulatory dossiers (CTD, eCTD) is a must.

Using digital & Microsoft Office tools; ability to collaborate effectively.

Strong interpersonal communication and organizational skills.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Job Purpose
Under general direction of the Regulatory Affairs Manager, the RA Specialist will do the required registrations on line and all related job requirements including communication with both teams at the supplier's side and inside Amico.

Key Responsibilities

• Understanding the registration requirements for several countries
• Requesting suppliers to provide different documents required for the registration
• Feeding the different governmental systems with the required registration information and uploading needed documents.
• Understanding the Comments received from the Authorities on any registration and passing it to the supplier in an easy understandable manner.
• Attending Conference calls with suppliers, prioritizing the requirements, conveying the needed tasks in an understandable manner
• Maintaining the Archive system
• Ability to bridge the communications between Authorities/our local agents in the countries with the supplier
• Follow the internal regulations in Amico
• Other regulatory activities such as classification, prequalification and recalls
• Communicating with the legal department in Amico for all legal concerns.
• Update the SOPs related to our processes when needed
• Close follow up for all pending issues
• Preparing reports related to the progress of work

Job Requirements

• Bachelor's degree or equivalent in Science, Pharmacy, Biomedical Engineering, Business Administration or Legal
• 3 years of experience in Regulatory Affairs with regional company (wide range of products)
• Worked for Medical Device Registration outside Egypt or to register Egyptian products with other countries
• Excellent Knowledge of MS Office.
• Fluent in English language
• Knowing the Pharmaceutical registration process
• Previous experience in registrations in the Gulf will be an added value
• Having a certificate in Quality or Regulatory Affairs will be an added Value

Why Join Us
At AMICO, we believe in fostering a diverse and inclusive workplace. We recognize the value that different perspectives and experiences bring to our company.
As part of our commitment to diversity, we encourage applications from all individuals as part of our inclusive hiring practices.
This initiative is part of our broader diversity agenda aimed at creating a balanced and innovative workforce

Job Title: Regulatory Affairs Specialist

Location:
Cairo

Department:
Regulatory Affairs

Reports To:
Regulatory Affairs Manager

Job Summary:

The Regulatory Affairs Specialist is responsible for ensuring compliance with all regulatory requirements for pharmaceutical, medical devices, or related products. This role involves preparing and submitting documentation to regulatory agencies, monitoring regulatory changes, and collaborating with cross-functional teams to ensure product compliance.

Key Responsibilities:

• Prepare and submit registration dossiers for new products and variations to the relevant authorities.
• Keep abreast of local, regional, and international regulatory changes and ensure compliance with applicable laws and regulations.
• Maintain accurate records of regulatory submissions and communications with regulatory agencies.
• Work closely with Quality Assurance, and Marketing teams to ensure that product development aligns with regulatory requirements.
• Conduct risk assessments and provide guidance on regulatory implications of product changes.
• Provide regulatory training and support to internal teams as needed.
• Participate in internal and external audits related to regulatory compliance.

Qualifications:

• Education
  : Bachelor's degree in Pharmacy, or a related field
• Experience
  : Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
• Knowledge
  : Strong understanding of local and international regulations (e.g., EDA, WHO standards).
• Skills
  :
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Proficient in Microsoft Office Suite and regulatory submission software.

Company Description

Since 1979, Ghalioungui Trading has been a key provider of surgical and medical supplies through importing, manufacturing, and distributing high-quality products. Our mission is to elevate health and wellness standards in Egypt and the region by delivering exceptional services and products. We are committed to our core values of humility, accountability, quality, resourcefulness, and integrity to achieve superior health solutions. We view access to health solutions as a basic human right and are dedicated to continuously improving and finding new ways to ensure this access.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Specialist, located in El Mokattam. The Regulatory Affairs Specialist is responsible for preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. The role involves staying updated with regulatory changes, coordinating with cross-functional teams to meet compliance, and maintaining accurate records of regulatory affairs activities.

Qualifications

• 1-2 years of Experience in regulatory affairs
• Experience in Regulatory Documentation and Regulatory Compliance
• Knowledge of Regulatory Requirements and expertise in Regulatory Affairs
• Proficiency in handling Regulatory Submissions
• Excellent organizational and time management skills
• Strong attention to detail and analytical skills
• Ability to work collaboratively in a team environment
• Bachelor's degree in a related field (e.g., Life Sciences, Pharmacy, or a similar discipline)
• Previous experience in the healthcare or pharmaceutical industry is a plus

Company Description

Founded in 1983, EGMED is the market leader in offering medical products and services, focusing on the assembly, manufacturing, and distribution of a wide range of medical products for hospitals and healthcare entities in Egypt, the Middle East, and Africa. EGMED collaborates with world-leading medical brands to provide comprehensive medical solutions. The company is dedicated to maintaining better health through reliable, cost-effective solutions and world-class maintenance and training services. EGMED's trusted products and effective partnerships have established it as one of Egypt's most reliable and impactful medical service providers.

Location: Cairo

Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist located in Cairo, Egypt. The Regulatory Affairs Specialist will be responsible for preparing regulatory documentation, ensuring regulatory compliance, and managing regulatory submissions and requirements. Day-to-day tasks include reviewing and preparing documents for regulatory approval, liaising with regulatory bodies, and staying updated on regulatory affairs to ensure the company's products meet all applicable regulatory standards.

Qualifications

Bachelor's degree in Pharmacy

2-4 years of experience, In medical equipment companies is a MUST

Excellent Communication Skills

Company Description

Future Pharmaceutical Industries (FPi) is an Egyptian Pharma company established in 2011 with the aim of creating a unique business environment in Egypt. Under the leadership of CEO Dr. Gamal El-Leithy, FPi has successfully launched 30 molecules and has over 50 more in the pipeline. The company emphasizes not only financial success but also a distinctive business culture through core values. FPi has passed several significant audits, including EMEA, Sanofi, Sandoz, and Novartis-OTC, and maintains regular compliance with the Egyptian Ministry of Health GMP standards.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Specialist located in New Cairo. The Regulatory Affairs Specialist will be responsible for preparing, reviewing, and submitting regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. The role entails close collaboration with various departments to ensure all activities meet regulatory standards and deadlines.

Qualifications

• Experience 1-3years with Regulatory Documentation, Regulatory Submissions, and Regulatory Requirements
• CTD practice is preferable
• Strong understanding of Regulatory Affairs and Regulatory Compliance
• Excellent attention to detail and organizational skills
• Ability to work effectively in a team environment
• Bachelor's degree in Pharmacy, Life Sciences, or a related field
• Previous experience in the pharmaceutical industry is a plus
• Strong written and verbal communication skills

Company Description

At Stio, healthcare is more than just medicine—it's about creating solutions that heal, restore, and transform lives. We focus on delivering essential medicines that address critical healthcare needs, with a commitment to ensuring quality and accessibility for all.

Rooted in innovation and purpose, Stio specializes in advanced therapies designed to support patients in cardiovascular health, respiratory care, sedation, and pain management. Since our founding in 2017, we have been driven by a vision to localize the production of high-quality pharmaceuticals while meeting the specific needs of Egypt, Africa, and the Middle East.

By combining cutting-edge science with compassionate care, we are striving to be the partner of choice for a healthier tomorrow.

Purpose of the position:

A regulatory affair Specialist ensures that products such as cosmetics, pharmaceuticals, veterinary medicines, food supplements, biocidal and medical devices meet legislative requirements. Regulatory affairs should have a skill set that's both broad and deep. Also, in charge to implement the company strategy and operations to maximize the process efficiency and productivity

The scope of work involves a complex combination of economics, science, public policy, law, and health. Regulatory affairs specialist requires attention to detail and the ability to speak the language of several different fields.

Duties and responsibilities:

• Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Prepare and put forward all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, incompliance with regulatory standards.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products files.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Manage activities such as manufacturing site audits, regulatory agency inspections, pharmacovigilance, or product recalls.
• Align Regulatory Affairs planning with business strategy and commercial objectives to ensure full synchronization and harmony.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Writing evidence-based reports on a new product.
• Writing executive summaries of new or changing regulations.
• Interfacing between business development, marketing, and senior management.
• Interpreting both scientific and legal documents.
• Obtaining regulatory authority for all marketing materials.
• Suggest solutions for process improvements.
• Identify process bottleneck and implement solutions in a timely manner.

Requirements and qualifications:

·   Previous working experience in Regulatory Affairs for 2 - 5 years.

·   Has Certificate of Attendance for CTD/eCTD and worked with it at least 1 year

·   Sense of ownership and pride in his performance and its impact on company's success

·   Critical thinker and problem-solving skills

·   Team player.

·   Good time-management skills.

·   Strong interpersonal and communication skills.

Excellent commend of computer skills.

Description

Gennecs Pharmaceuticals Ltd is a research-based pharmaceutical company specializing in the development and production of innovative vaccines and biological products. The company is dedicated to commercializing products for Egypt, Africa and MENA regions. We are looking for Regulatory affairs professional
(Specialist/ Sr.Specialist/ Supervisor)
reporting into the Regulatory Affairs Manager-
Vaccines
, with
CTD , e-CTD
experience
to establish effective relations with the local regulatory authority to accelerate patient access to our brands. This is a full-time on-site role in Cairo, Egypt.

This role is for a
go-getter
, who is passionate, innovative and persistent enough to get things done, while maintaining full compliance with laws, regulations and company values.

Key Responsibilities

• Ensure understanding of the Vaccines regulatory competitive environment, trends and legislation to adapt regulatory strategy and to meet future requirement accordingly.
• Ensure top quality across all regulatory submissions and planning for dossiers preparation.
• Ensure compliance with applicable internal guides and pharmaceutical legislations with regard to all activities.
• Efficient execution and processes in accordance with EDA regulations and requirtements.
• Managing Product review cycles as standalone responsibility.
• Manage all pricing files submissions either new or adjustments.
• Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain products.
• Contribute to strategic and technical input/support to drive implementation of systems, tools and processes to support development projects and/or marketed products.
• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
• Identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers
• Maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

Qualifications

• Bachelor degree of Pharmacy or equivalent.
• Minimum of 2 years of experience in pharmaceutical regulatory environment.
• Strong Communication and Networking Capabilities.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Pharmaceutical Products Regulations is a MUST, Bilogicals and / or Vaccines knowledge is needed
• Send an email to

with the title (Regulatory Affairs Professional)