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Regulatory Affairs Manager

3 weeks ago

Bengaluru, Karnataka, India Bionova Lifesciences Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Manager to oversee regulatory submissions, ensure compliance with national and international pharmaceutical & FSSAI regulations, and maintain product registrations.

Main Responsibilities:
  • Develop and implement regulatory strategies for pharmaceutical, nutraceutical, and cosmetic products.
  • Ensure compliance with local and global regulations (e.g., CDSCO, FSSAI, USFDA, EU EMA, etc.).
  • Stay updated on changing regulatory requirements and provide guidance to internal teams.
Dossier Preparation & Submission

Key responsibilities include preparing, compiling, and submitting dossiers for new product registrations, renewals, and variations. Ensuring accuracy in regulatory filings, including CTD/eCTD submissions is crucial. Managing responses to regulatory queries and deficiencies is also essential.

Liaison with Regulatory Authorities

The ideal candidate will establish and maintain communication with CDSCO, FSSAI, state FDA, and other regulatory bodies. Participating in meetings and audits with regulatory authorities and attending customer audits are key aspects of this role.

Cross-functional Collaboration

This position requires working closely with R&D, Quality Assurance, Marketing, and Manufacturing teams for regulatory support. Providing regulatory inputs for product development and market expansion is also a key responsibility.

Qualifications & Skills:
  • Educational background in M. Pharm / B. Pharm / MSc in Regulatory Affairs, Pharmacy, or Life Sciences.
  • Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical/nutraceutical/cosmetic industry.
  • Technical expertise in regulatory guidelines (CDSCO, FSSAI, ICH, WHO-GMP, USFDA, EU EMA).
  • Familiarity with pharmacovigilance and post-marketing surveillance regulations.