Regulatory Affairs Executive

3 days ago


Mumbai, Maharashtra, India IMPACT LABS Private Limited Full time ₹ 1,80,000 - ₹ 3,60,000 per year

Licensing & Approvals:

  • Obtain product permissions from relevant regulatory authorities.
  • Prepare and submit applications for new manufacturing licenses.
  • Liaise with government agencies to ensure timely approvals and renewals

Dossier Compilation:

  • Compile, review, and submit regulatory dossiers in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document) formats.
  • Ensure documentation complies with national and international regulatory standards.
  • Coordinate with internal departments to gather required technical and quality data.

Artwork Compliance:

  • Review product artwork and labeling to ensure alignment with regulatory standards and country-specific requirements.
  • Provide feedback and corrections to design teams to maintain compliance.

Qualifications & Skills:

  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
  • 2–5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.
  • Strong understanding of regulatory guidelines (e.g., CDSCO, ASEAN).
  • Proficiency in dossier preparation and submission processes.
  • Excellent communication and documentation skills.

Job Types: Full-time, Permanent

Pay: ₹180, ₹360,000.00 per year

Benefits:

  • Health insurance

Work Location: In person



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