Regulatory Affairs Executive

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: ₹180,000.00 - ₹360,000.00 per year

Benefits:

• Health insurance

Work Location: In person