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Manager - Advanced Biotech Lab (Biosimilar) Regulatory Affairs @ Ipca

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 Manager - Advanced Biotech Lab (Biosimilar) Regulatory Affairs

Job Description

Hello,


We have urgent opening for the below profile


Key Responsibilities:

  • Responsible for biosimilar dossier authoring for regulatory filings for Global markets
  • Independent project responsibility in RA
  • Responsible for cross functional coordination & support (R & D and Bio-manufacturing)

Key Competencies:

  • Regulatory dossier authoring and submissions
  • Query response preparation and troubleshooting
  • Assessment of change controls impacting regulatory submissions
  • Regulatory document review and follow up on the timelines
  • Coordination and support cross-functional activities
  • Document review (R & D and Bio-manufacturing)
  • Presentation on updated regulatory guidelines and implementation across R & D and Bio-manufacturing

If you think that you fit the role, please share your updated copy of resume on sa*********e@ip*a.com with Total years of Experience, Current CTC, Expected CTC, Notice Period,Current Location,,Reason for leaving.


Please contact me for more details #9833477***

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Pharmaceutical & Biotechnology - Other
Employement Type: Full time

Contact Details:

Company: Ipca
Location(s): Mumbai

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Keyskills:   Regulatory Affairs Biotechnology Dossier Preparation Regulatory Reports Regulatory Compliance Regulatory Submissions

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