Regulatory Affairs Specialist

10 hours ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Our organization is seeking a highly skilled professional to fill the role of Regulatory Affairs Specialist - Clinical Trials. This position involves developing strategic plans for biosimilar clinical development, designing and implementing protocols for clinical trials, reviewing and finalizing applications, and preparing regulatory submissions.

The ideal candidate will have 5-15 years of experience in RA-Clinical Trials and hold a degree in M.Pharm/B.Pharm. Strong knowledge of regulatory affairs, clinical trials, and biologics dossier authoring is required.

  • Develop Biosimilar Clinical Development Strategy
  • Design and develop biosimilar clinical trials protocols
  • Review and finalize biosimilar clinical trial applications
  • Author and review biologics/biosimilar dossiers
  • Prepare eCTD submissions
  • Manage product life cycle
  • Support RA activities for plant-related QMS

This is a challenging opportunity for someone looking to leverage their skills and experience in RA-Clinical Trials. We offer a supportive environment where professionals can grow and contribute to our success.

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