Biocon Biologics
Website:
bioconbiologics.com
Job details:
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.
Click on Apply to know more.