Senior Regulatory Manager

3 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time

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/eCTD 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

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