Regulatory Affairs Specialist
1 day ago
Company Overview
Enterslice, a leading provider of regulatory solutions, is seeking an experienced Regulatory Affairs Specialist to join our team. Our company is dedicated to driving regulatory excellence and compliance in the healthcare and cosmetic sectors.
Job Summary
We are looking for a highly skilled Regulatory Affairs Specialist with expertise in CDSCO filings, Cosmetic Rules 2020, and regulatory submissions. The ideal candidate will have experience handling licenses for Medical Devices, IVDs, and Drugs, as well as a strong understanding of ISO standards and Indian MDR-2017 guidelines.
Key Responsibilities:
- CDSCO Filings: Prepare and submit applications for Manufacturing, Import, Test, and Loan Licenses (Class A, B, C & D).
- Document Management: Manage retention, endorsement, voluntary registration, and wholesale licenses (MD-42) as per MDR-2017 (CDSCO).
- Device Documentation: Draft Device Master File (DMF) and Site Master File (SMF).
- Drug Licensing: Handle applications for Drug Licenses (Forms 20, 21, etc.), changes, and renewals under the Drug & Cosmetics Act, 1940.
- Cosmetic Licensing: Manage applications for Import, Manufacturing, and Loan Licenses (COS-1, COS-5, etc.) under Cosmetic Rules, 2020.
- Compliance & Documentation: Maintain QMS documentation (ISO-13485, ISO-14971), prepare SOPs, and respond to regulatory queries.
Qualifications:
- Masters degree in Environmental Science, Regulatory Affairs, or a related field.
- 1–3 years of experience in Regulatory Affairs (CDSCO, Drugs, or Cosmetics).
Salary: ₹800,000 - ₹1,200,000 per annum, depending on qualifications and experience, plus benefits such as medical insurance, retirement plan, and paid time off. If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply.
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