
Regulatory Affairs Officer
GMH Organics Private Limited
Baddi, Himachal Pradesh, India
Posted on 21-08-2025
1 Vacancy
Description
- Prepare, review, and submit dossiers, CTD/eCTD, and regulatory documents to authorities.
- Ensure compliance with national and international drug regulations (USFDA, EMA, WHO, CDSCO, etc.).
- Coordinate with R&D, QA, QC, and Production teams for regulatory submissions.
- Handle product registrations, renewals, and variations as per regulatory guidelines.
- Maintain up-to-date knowledge of changing regulatory requirements.
- Review labeling, artwork, packaging, and promotional materials for compliance.
- Support regulatory audits, inspections, and responses to authority queries.
- Maintain regulatory databases, records, and submission tracking systems.
- Assist in lifecycle management of products across global markets.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Good Communication SkillsAttention to DetailDecision MakingProblem SolvingTeam working Skills
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