Regulatory Affairs Manager

3 days ago

Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full time

Role & responsibilities

Role Overview:

The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission.

Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory submissions (CTD/eCTD) in line with EU/UK/and other global regulatory requirements. The role requires close coordination with cross-functional teams (Formulation, Analytical, Quality, Production, and Packaging) to ensure timely and compliant dossier submissions.

Responsibilities :

  • Compile, review, and manage dossiers (Modules 1-5) for regulatory submissions via MRP, DCP, and national procedures according to EMA and ICH guidelines in eCTD format.
  • Ensuring and responsible for CMC activities, pre submission dossier preparation, post approval variation activities and life cycle management of the dossier.
  • Prepare, review, and update Module 3 (Quality/CMC) sections for new submissions
  • Responsible for reviewing and approvals of documentation for tech transfers projects from R&D as well as finished product manufactures, API manufactures, raw material manufactures
  • Evaluate and perform scientific literature searches for reference products, market analysis, bioequivalence, and biowaiver strategies.
  • Support review and compilation of relevant parts of Module 2 (Quality Overall Summary) and relevant cross-references in Modules 1 and 2.
  • Ensure documents and data comply with EMA, MHRA, FDA, and ICH guidelines.
  • Liaise with internal teams and CMOs for timely receipt of technical data and reports.
  • Review technical reports such as process validation, analytical validation, and stability data for regulatory adequacy.
  • Manage project coordination and multitasking across departments
  • Compile and respond to deficiency letters during assessment phases within timeframe including post approval variations.
  • Ensure proper documentation and adherence to Good Laboratory Practices (GLP), supporting audits as required.

Preferred candidate profile

  • B.Pharm/ M. Pharm / M.Sc. in Pharmaceutical Sciences or related field.
  • 8-10 years of hands-on experience in Regulatory Affairs CMC / Quality documentation specifically in UK and Europe
  • Working knowledge of CTD/eCTD format and global submission requirements.
  • Proficiency in MS Office and document management tools.
  • Excellent communication, coordination, and time management skills and skills to work with internal team.

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