
Biosimilar Product Regulatory Lead
2 days ago
The role of Regulatory Compliance Manager will involve overseeing regulatory activities for biosimilar products in the LATAM region.
- Develop and implement regulatory strategies for biosimilar products in LATAM, ensuring compliance with regional regulations.
- Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.
- Evaluate and implement regulatory changes impacting product lifecycle management.
- Manage post-approval activities including labeling updates, renewals, and change control assessments.
- Ensure compliance with regional regulations and company SOPs.
- Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.
- Liaise with local health authorities, business partners, and internal teams (CMC, QA, PV, Medical Affairs).
- Support agency meeting preparations and GMP certification processes.
- Assess regulatory impact of manufacturing and quality changes.
Requirements: Minimum 4 years of experience in Regulatory Affairs within the pharmaceutical/biotech industry. Responsibilities: Involves managing and leading multiple projects simultaneously.
We offer a dynamic work environment with opportunities for professional growth and development.
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Bengaluru, Karnataka, India Biocon Biologics Full timeAbout the CompanyAt Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural...