Regulatory Affairs Specialist
4 weeks ago
We are seeking a skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. This role is responsible for preparing and reviewing dossiers in various formats for the ROW market, as well as coordinating with QA/QC departments and local regulatory authorities.
Key Responsibilities:
- Preparation and submission of Site GMP Applications and Product Registrations
- Liaisoning with Local FDA and CDSCO for product permissions and certifications
- Artwork designing for registration sample preparation and submission
- Preparation and review of technical documents, including BMR, PVP/PVR, and Specification
- Document preparation for national and international tenders
Requirements:
- B.Pharm, M.Pharm, or D.Pharm qualification
- 2-3 years of experience in regulatory documentation
- Excellent communication and coordination skills
Salary: 20k to 25k CTC
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Regulatory Affairs Specialist
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Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. The successful candidate will be responsible for preparing and reviewing dossiers in various formats, coordinating with QA/QC departments, and ensuring compliance with regulatory...
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