The Role
Lead and support regulatory filings for biosimilars and NCEs, manage IND/CTA submissions, and provide regulatory guidance.
Summary Generated by Built In
Description
- Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs,
- Query responses, audit support, and lifecycle management.
- Regulatory support for the filing of IND/CTA to various regulatory agencies.
- Maintenance of IND/CTA through submission of protocol amendments, addition of investigators, EC approvals, SAE report submission, quarterly/annual Report, etc.
Interested Candidates Please share the resumes at [email protected]
Requirements
- Education: Masters in biotechnology /Pharma- Regulatory Affairs/Pharmaceutical Biotechnology
- Experience: 12-15 Years
- Skills: Exposure in Emerging markets, Regulated Markets, Regulatory guidance, Dossier Preparation, Biosimilars and NCEs
Skills Required
- Masters in biotechnology or Pharmaceutical Biotechnology
- 12-15 years of experience
- Exposure in emerging markets and regulated markets
- Regulatory guidance experience
- Dossier preparation skills
- Experience with Biosimilars and NCEs
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The Company
What We Do
Kashiv BioSciences is a fully-integrated biopharmaceutical company with global R&D, clinical, manufacturing, regulatory, and IP capabilities, focusing on developing and manufacturing biosimilars and complex peptide medicines to improve access to important therapies.
