Regulatory Affairs

Organisation:

Positions, Experience & Vacancies (Regulatory Affairs)

Position LevelExperienceVacancies

Sr. Manager / Manager 15-20 yrs -1

Manager / Asst. Manager 10-15 yrs -2

Sr. Executive / Executive 5-10 yrs -4

Combined JD Regulatory Affairs (All Levels)

Job Purpose

To manage regulatory documentation, global submissions, compliance activities, and coordination with internal teams for API products to support timely approvals and lifecycle management.

Key Responsibilities

• Prepare, review, and compile regulatory dossiers:

  DMFs, CTDs, ANDAs, eCTDs

  , and other international submissions.
• Ensure all regulatory documents comply with

  global regulatory agency guidelines

  (USFDA, EMA, WHO, etc.).
• Collect and verify technical data from

  QA, QC, R&D, Production

  for dossier preparation.
• Review specifications, stability reports, validation data, and batch documents for regulatory accuracy.
  
• Support responses to regulatory authority queries and deficiency letters.
  
• Maintain submission trackers, regulatory databases, and lifecycle records.
  
• Assess regulatory impact for

  change controls

  and support post-approval updates.
• Ensure compliance with

  GMP

  and internal SOPs.
• (For senior roles) Lead regulatory strategy, mentor junior staff, and coordinate agency interactions.