Senior Regulatory Affairs Specialist

2 days ago

محافظة القاهرة, 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.

**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.

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