Senior Regulatory Affairs Specialist

We are looking for an experienced Regulatory Affairs professional with strong 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.