Senior Regulatory Compliance Specialist

4 days ago

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

Job Overview

Our organization is seeking an experienced Regulatory Manager to join its team. As a key member of the regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and maintaining strong relationships with regulatory agencies.

Key Responsibilities:

  • Maintain Cell Therapy guidelines, USFDA guidelines, EMA.
  • Animal Safety & efficacy studies with GLP certified laboratory/testing facility (Preclinical and non-clinical related activities).
  • Knowledgeable in validation of analytical methods and analytical methodology.
  • Extensive knowledge of Pharmacology, Pharmacokinetics, Toxicology, Genotoxicity, Carcinogenicity, Local Tolerance.
  • Present and conduct meetings with regulatory agencies, CROs, national & international authorities.
  • Reporting weekly, monthly, quarterly, yearly meetings, updates, improvements.

Functional Area:

  • Quality Assurance, QA, QA Head, Head Quality, Regulatory Affairs Executive, Regulatory Affairs, Quality Assurance Manager, CMC, Stem Cells Theraphy, Cells Therapy, Biopharma, Biotechnology.

Requirements:

  • Post-Marketing Experience.
  • Statutory fulfillment.
  • Efficacy and Safety Studies.
  • Clinical trial and prepare Clinical Study Reports.

Preferred Skills:

  • Safety pharmacology studies for human pharmaceuticals.
  • Single dose toxicity and repeated dose toxicity.

About the Role:

This role plays a critical part in ensuring that our operations are compliant with relevant laws and regulations. The ideal candidate will have a strong background in regulatory affairs and excellent communication skills.

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