Regulatory Affairs Manager

Job description

**Job Description** We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, LATAM) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. **Key Responsibilities:** • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for Biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, LATAM, and Africa. • Support product registrations, renewals & variations. • Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. • Respond to health authority queries in coordination with CMC, clinical, and quality teams. • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. • Familiarity with GCC-CTD and regional WHO biosimilar guidelines. • Experience working with local affiliates or partner companies in Emerging Markets. • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. • Experience with regional electronic submission platforms. **Qualifications:** • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field. • Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. • Knowledge of CTD structure, Module 1 customization, and regional submission formats. • Strong project management, communication, and stakeholder coordination skills.