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Join Bharat Serums and Vaccines Limited (BSV), a USFDA-approved, leading biopharmaceutical company, as an Assistant Manager/Manager in Regulatory Affairs at our Airoli, Navi Mumbai office. A subsidiary of Mankind Pharma, BSV generates ₹1,500 Crore revenue (FY24 estimate) and employs 1,000+ professionals across 70+ countries.
Rated 4.0/5 on AmbitionBox (586+ reviews) for work-life balance (3.8/5), salaries range from ₹8–15 Lakhs/year for regulatory roles (Glassdoor). With a mission of “Bringing Life to Life,” BSV focuses on women’s health, critical care, and IUI-IVF. Be part of our journey to deliver innovative biological and biotech products globally
Job Posting Details
- Role: Assistant Manager/Manager
- Department: Regulatory Affairs
- Location: Registered & Corporate Office, 3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza, Kalwa Industrial Estate, Airoli, Navi Mumbai, Thane, Maharashtra 400708
- Application: Email resume to careers@bsvgroup.com with subject: “Applying for Regulatory Affairs.”
- Contact: +91-22-2778-6000, careers@bsvgroup.com
- Website: www.bsvgroup.com
Notes:
- Fraud Alert: BSV does not charge fees or accept payments for jobs. Report suspicious communication to careers@bsvgroup.com.
Why BSV?
Founded in 1971, BSV is among India’s top 10 biotech companies, with 145+ brands in plasma derivatives, monoclonals, fertility hormones, and equine immunoglobulins. Its USFDA-approved Ambernath plant and Germany API facility drive innovation in women’s health (e.g., Trinbelimab for Rh incompatibility) and critical care (e.g., Amphonex).
Rated 3.7/5 for skill development (Indeed), BSV offers robust training but scores 3.3/5 for career growth due to moderate promotions (AmbitionBox). Benefits include health insurance, canteen, and flexi-hours. BSV’s 2024 acquisition by Mankind Pharma (₹13,768 Crore) strengthens its leadership in fertility and critical care markets.
Job Position: Assistant Manager/Manager – Regulatory Affairs
- Qualification: B.Pharm, M.Pharm, M.Sc (Biotechnology, Chemistry)
- Experience: 5+ years in regulatory affairs for biological/biotech products
- Vacancies: ~2–4 (estimated)
- Location: Airoli, Navi Mumbai, Maharashtra
Skills:
- Expertise in dossier preparation and submission for emerging markets (Asia Pacific, Latin America, Africa).
- Proficiency in post-approval change filings (e.g., CMC variations, labeling updates).
- Knowledge of USFDA, EMA, CDSCO, and WHO guidelines for biologicals/biotech products.
- Familiarity with eCTD, QMS, GMP, and regulatory query responses.
- Strong documentation, stakeholder coordination, and audit-facing skills.
Job Description:
- Prepare and submit regulatory dossiers for biological/biotech products in emerging markets, ensuring compliance with regional guidelines.
- Manage post-approval change filings, including CMC variations, manufacturing changes, and labeling updates.
- Respond to regulatory queries from authorities (e.g., CDSCO, WHO) in a timely manner.
- Maintain master databases for regulatory submissions and approvals.
- Review MF, BMR, and protocols to ensure compliance with ICH Q8-Q10 and GMP.
- Coordinate with R&D, QA, and manufacturing teams for tech transfer and regulatory alignment.
- Support USFDA/EMA audits and internal QMS activities (e.g., CAPA, deviations).
- Monitor regulatory updates in emerging markets to guide strategy.
Why Join?: Shape regulatory strategies for BSV’s biotech portfolio, impacting women’s health and critical care globally.
Who Can Apply?
- Qualifications: B.Pharm, M.Pharm, M.Sc (Biotechnology, Chemistry).
- Experience: 5+ years in regulatory affairs, specifically with biological/biotech products (e.g., monoclonals, hormones, plasma derivatives).
- Key Skills:
- Regulatory: Dossier preparation, post-approval filings, eCTD, query responses.
- Technical: GMP, QMS, ICH Q8-Q10, audit readiness.
- Markets: Emerging markets (Asia Pacific, Latin America, Africa).
- Strong communication, documentation, and cross-functional coordination.
- Preferred: Experience with fertility hormones or injectables, USFDA/EMA audit exposure, knowledge of CDSCO/WHO guidelines, local candidates (Navi Mumbai/Thane).
How to Apply
- Submit Resume: Email to careers@bsvgroup.com with subject: “Applying for Regulatory Affairs.” Highlight experience in biological/biotech products and emerging markets.
- Prepare Documents: If shortlisted, bring CV, mark sheets, degree certificate, experience letters, last 3 months’ payslips, CTC breakup, Aadhaar/PAN copies, 2 photos.
Study Up:
- Review dossier preparation (eCTD format), post-approval change filings, and regulatory guidelines (USFDA, EMA, CDSCO, WHO).
- Study BSV’s portfolio (e.g., Trinbelimab, Amphonex, fertility hormones). Visit www.bsvgroup.com.
- Prepare examples (e.g., “How did you manage a post-approval CMC variation?” or “How did you respond to a CDSCO query?”).
- Understand QMS processes (e.g., CAPA, deviations) and audit readiness.
- Address career growth concerns diplomatically (28% rate promotions ≤3/5, AmbitionBox).
Verified by Trusted HRs
The post is released by the BSV Limited LinkedIn page. Click here to visit the post
Interview: Expect technical (70%) and behavioral (30%) questions. Emphasize regulatory experience, audit exposure, and emerging market knowledge. Process takes ~1 week (Indeed).
Why Airoli, Navi Mumbai?
BSV’s Airoli office, 25 km from Mumbai via NH-48, is part of Maharashtra’s $10 billion pharma sector (10% CAGR, Invest India). Navi Mumbai offers 500+ biotech jobs (Naukri) and affordable living (₹15,000/month for 1BHK, AmbitionBox). Accessible via local trains (Airoli station) and NMMT buses, it’s ideal for regulatory careers in biopharma.
Contact Information
- Email: careers@bsvgroup.com
- Phone: +91-22-2778-6000
- Location: 3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza, Kalwa Industrial Estate, Airoli, Navi Mumbai, Thane, Maharashtra 400708
- Ambernath Plant: Plot No. K-27, Anand Nagar, Jambivili Village, Additional M.I.D.C, Ambernath (East), Thane, Maharashtra 421501
- Corporate Office: Mankind Pharma Ltd., 262, Okhla Industrial Estate Phase-III, New Delhi 110020
- Connect: LinkedIn, Facebook
- Website: www.bsvgroup.com
Apply Now for the Assistant Manager/Manager – Regulatory Affairs role at BSV in Airoli, Navi Mumbai, and contribute to innovative biotech solutions!