Senior Regulatory Affairs Specialist

2 days ago

Cairo, Egypt IQVIA Full time

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.
- 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.
- 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.

  • Senior Regulatory Affairs Specialist

    1 week ago

    New Cairo, Cairo, Egypt Napco Pharma ( NATIONAL COMPANY FOR PHARMACEUTICAL INDUSTRIES ) Full time 90,000 - 120,000 per year

    Company DescriptionNAPCO PHARMA is an Egyptian pharmaceutical company with a portfolio of over 350 products spanning all therapeutic areas. Operating from a state-of-the-art GMP and ISO certified manufacturing facility in Egypt, the company is dedicated to delivering high-quality pharmaceuticals at competitive prices. NAPCO PHARMA exports its products to 15...

  • Regulatory Affairs Specialist

    6 hours ago

    Cairo, Cairo, Egypt Qvetech Full time

    Role DescriptionThis is a full-time, on-site role for a Regulatory Affairs Specialist located in Cairo. The Regulatory Affairs Specialist will be responsible for preparing, coordinating, and submitting regulatory documentation in compliance with applicable regulations. The role involves ensuring adherence to regulatory requirements, managing regulatory...

  • Regulatory Affairs Specialist

    1 week ago

    Cairo, Cairo, Egypt Grifols Egypt for Plasma Derivatives (GEPD) Full time 60,000 - 120,000 per year

    Job ObjectiveRegulatory Affairs Specialist is responsible for assisting in obtaining and maintaining National Health Authorities (EDA) and International approvals (as required) for Plasma supply chain facilities, products Manufacturing Facility, Plasma Exportation and finished product importation and release.Key responsibilityPrepare and submit all...

  • Regulatory Affairs Specialist

    6 days ago

    Cairo, Cairo, Egypt Kemet Medical Full time 40,000 - 80,000 per year

    Company DescriptionKemet Medical, a 40-year-old medical equipment company, is dedicated to providing innovative, high-quality healthcare technologies combined with exceptional customer service to empower caregivers in enhancing patient lives. Over the years, we have grown from a small team of 10 employees to a thriving organization of over 150 team members,...

  • Regulatory Affairs Specialist

    1 week ago

    Cairo, Cairo, Egypt GESCA Full time 40,000 - 60,000 per year

    The Regulatory Affairs Specialist will be primarily responsible for managingimportation approvalsfor medical devices and consumables — ensuring full compliance with EDA regulations and supporting in registration, vigilance, variation, controlled release, inspection and compliance.Key Responsibilities:Obtain importation approvals from regulatory...

  • Regulatory Affairs Specialist, Egypt

    1 week ago

    Cairo, Egypt Johnson & Johnson Full time

    **Job Function**: Regulatory Affairs Group **Job Sub**Function**: Regulatory Product Submissions and Registration **Job Category**: Professional **All Job Posting Locations**: Cairo, Egypt **Summary of the job**: The main task of a Regulatory Affairs Specialist in Johnson & Johnson is to Develops skill set to enable value added individual contributions,...

  • Regulatory Affairs Specialist

    1 week ago

    Cairo, Cairo, Egypt Eva Pharma Full time 120,000 - 180,000 per year

    Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.  Job Summary:We are seeking a passionate and talented Regulatory Affairs...

  • Senior Regulatory Affairs Associate

    1 week ago

    Cairo, Egypt Johnson & Johnson Full time

    **Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Cairo, Egypt **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that...

  • Senior Regulatory Affairs Coordinator

    2 weeks ago

    Cairo, Egypt IQVIA Full time

    _Advance healthcare with IQVIA - where your expertise drives innovation and compliance._ **About the Role** As a Senior Regulatory Affairs Coordinator at IQVIA, you will play a critical role in ensuring regulatory compliance and supporting submissions of Cosmetics, Nutritional Products, and Medical Devices across Egypt and GCC. You’ll collaborate with...

  • Regulatory Affairs Lead

    4 days ago

    Cairo, Egypt AstraZeneca Full time

    **Introduction to role**: Are you ready to be part of the team of Regulatory affairs for Near East & Maghreb Countries markets? As the Regulatory Affairs Lead, you'll ensure AstraZeneca's "License to Operate" regulatory activities are met for all products, aligning with Near East & Maghreb Countries markets legislation and our code of "Good Regulatory...