Officer to Sr. Executive-Regulatory Affairs
SP Accure Labs Pvt Ltd
Medchal Malkajgiri, Telangana, India
Posted on 11-12-2025
1 Vacancy
Description
- repare, review, and submit regulatory documents for product approvals and renewals.
- Ensure compliance with national and international regulatory guidelines (CDSCO, FDA, WHO, EMA, etc.).
- Coordinate with R&D, QA, QC, and Production teams to gather required technical data.
- Maintain product dossiers, CTD/eCTD files, and regulatory databases.
- Review product artwork, labels, and packaging for regulatory accuracy.
- Track regulatory changes and update internal teams on new requirements.
- Handle product registration, license applications, and variations.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Decision MakingAttention to DetailGood Communication SkillsProblem Solving
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