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Senior regulatory manager
4 weeks ago
We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) 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/e CTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, 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, ASEAN 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
