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

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 Posted 88 days ago — confirm the vacancy is still active.

 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 [email protected] with Total years of Experience, Current CTC, Expected CTC, Notice Period,Current Location,,Reason for leaving.


Please contact me for more details #0983347...

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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Ipca

Startek is a global provider of customer experience management and business process outsourcing solutions, serving industries such as telecom, healthcare, banking, and retail. The company offers services including customer care, technical support, collections, and back-office operations, leveraging ...

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