
Regulatory Affairs Executive
6 days ago
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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