Senior Biosimilar Development Specialist

7 days ago


Mumbai, Maharashtra, India beBeeBiosimilar Full time ₹ 12,64,500 - ₹ 21,47,000
Job Overview:

Our organization seeks a seasoned professional to develop and implement biosimilar clinical development strategies, oversee clinical trial design and management, and author biosimilar dossiers.

The ideal candidate will be responsible for:

  • Designing and implementing comprehensive clinical development plans for biosimilars in the EU and US markets
  • Developing and managing clinical protocols for biosimilar products in the EU and US markets
  • Overseeing the preparation and submission of clinical trial applications and reports to regulatory authorities in the EU and US
  • Authoring and reviewing biologics/biosimilar dossiers for eCTD submissions in the EU and US markets
  • Providing RA support for quality management system activities


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