Senior Regulatory Affairs Executive

15 hours ago


Ahmedabad, Gujarat, India Red Envelope Consultants Full time US$ 90,000 - US$ 1,20,000 per year

Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially)

Location: Ahmedabad

Experience: 5–7 years in Regulatory Affairs (RoW markets)

Qualification: B.Pharm / M.Pharm / Life Sciences

Key Responsibilities:

  • Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations.
  • Coordinate with agents/distributors for submissions and query responses.
  • Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia).
  • Manage product lifecycle: variations, renewals, packaging/labelling updates.
  • Maintain regulatory databases and trackers.

Key Skills:

  • Strong knowledge of RoW regulatory requirements & dossier formats.
  • Experience with LATAM countries (Brazil, Mexico, Argentina, Chile, etc.).
  • Excellent documentation, coordination & communication skills.
  • Proficiency in MS Office & regulatory databases.

Other Details:

  • Will lead a team of 4 RAs and report to Director.
  • Immediate joiners preferred (short notice period).


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