Senior Regulatory Affairs Specialist (Navi Mumbai)

Senior Regulatory Affairs Specialist (Navi Mumbai)

15 Oct
|
CliniLaunch Research Institute
|
Navi Mumbai

15 Oct

CliniLaunch Research Institute

Navi Mumbai

We are looking for an experienced Regulatory Affairs professional with solid hands-on exposure to CMC / Technical Regulatory Affairs and pharmaceutical products.
Position: Senior Regulatory Affairs Executive
Location: Work From Home (Remote)
Experience: 2–4 Years
Salary: Up to ₹40,000 Gross/Month
KEY REQUIREMENTS
The candidate should have experience in:
• CMC / Technical Regulatory Affairs – Mandatory
• Injectable Products
• OSD (Oral Solid Dosage) Products
• Exposure to Biosimilars / Biological Products will be an advantage
• Experience with other pharmaceutical products
• CTD/eCTD and Module 3 – Quality/CMC
• Regulatory dossier preparation and review
• Regulatory submissions and response to regulatory queries
• Coordination with R&D;, QA, QC,



Manufacturing and Analytical teams
QUALIFICATION
Candidates must have any of the following qualifications:
• B.Pharm
• M.Pharm
• Pharm.D
IDEAL CANDIDATE
We are looking for candidates with 2–4 years of relevant Pharmaceutical Regulatory Affairs experience, particularly those with strong technical knowledge of CMC documentation and hands-on exposure to Injectable and OSD products.
Candidates who have worked with Biosimilars/Biological products or multiple pharmaceutical product categories will have an added advantage.

📌 Senior Regulatory Affairs Specialist (Navi Mumbai)
🏢 CliniLaunch Research Institute
📍 Navi Mumbai

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