Roles and Responsibilities
- Prepare dossiers for regulatory submissions (CTD) for countries like Latam and Row market.
- Compile data from various sources into CTD format.
- Ensure timely compilation of dossier documents.
- Coordinate with cross-functional teams for document preparation.
- Review and finalize dossiers before submission.
- Post submission query response
- Artwork review before submission
- Preparation of SMPC and Pack insert
Desired Candidate Profile
- 1-3 years of experience in Regulatory Affairs, preferably in Oral Solid Dosage formulations.
- B.Pharma - Bachelor of Pharmacy degree in Any Specialization; M.Pharma - Master's degree preferred but not mandatory.
- Strong understanding of drug regulatory affairs
- maceutical or healthcare sector is preferred
