Biosimilar Product Regulatory Lead

2 days ago


Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Compliance Manager

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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