16 Oct
|
CliniLaunch Research Institute
|
Navi Mumbai
16 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