
Assistant Manager-Regulatory Affairs
Beta Drugs Ltd
Baddi, Himachal Pradesh, India
Posted on 02-09-2025
1 Vacancy
Description
- Prepare, review, and submit regulatory dossiers (CTD/eCTD) for global markets.
- Ensure compliance with local and international regulatory guidelines.
- Coordinate with R&D, QA, QC, and Production for data compilation.
- Handle product registration, renewals, and variations with regulatory authorities.
- Maintain regulatory databases, records, and submission tracking systems.
- Respond to regulatory queries and deficiencies in a timely manner.
- Monitor changes in regulatory requirements and update teams accordingly.
- Review labeling, artworks, and packaging for compliance.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Good CommunicationAttention to DetailDecision-MakingProblem Solving Skills
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