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Regulatory Affairs Specialist

1 month ago

Ahmedabad, Gujarat, India Lifelancer Full time

About the Job

We are seeking a highly skilled Regulatory Affairs professional to join our team at Lifelancer. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products.

Key Responsibilities:

  • Preparation and review of dossiers in ACTD, CTD, or country-specific formats for ROW markets.
  • Preparation and submission of Site GMP applications and product registrations with respective regulatory authorities.
  • Liaisoning with local FDA and CDSCO for product permissions and COPP inclusion.
  • Coordination with QA/QC departments for technical and legal documents.
  • Artwork designing for registration, sample preparation, and submission.
  • Preparation and/or review of technical documents, including BMR, PVP/PVR, specification, MOA, COA, and raw material, finished product, and packing materials.
  • Document preparation for national and international tenders.
  • MOH query response and resolution within stipulated timelines.

About Lifelancer

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Please use the below Lifelancer link for job application and quicker response: /jobs/view/cc524b97bd6bdfd81636f

Remote Work: No