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Regulatory Affairs- Domestic

4 weeks ago

Mumbai, India Talent Leap Private Limited Full time

Designation
: Sr. Executive/Asst. Manager/Deputy Manager

Location
: Mumbai.

Qualification
: B. Pharm./M. Pharm.

Experience
: 2+ Years of relevant experience in Domestic Market

Industry
: Pharmaceutical

CTC
: Best In Industry

The role involves managing regulatory processes under D&C Act, FSSAI, and FDA guidelines. Responsibilities include preparing registration dossiers, coordinating with R&D and QC for documentation, handling FDA/DCGI/FSSAI licenses and renewals, and ensuring compliance through online portals like Sugam. You'll oversee regulatory submissions, label/artwork compliance, packaging reviews, and maintain proper documentation.

In addition, the role involves basic pharmacovigilance work like drafting PSURs, reviewing risk management plans, and ensuring product safety reporting aligns with regulatory standards.

Share your resumes to if you have relevant experience and interested for this opportunity.