Job DescriptionWe're Hiring | Vice President – Quality & Regulatory Affairs

NMumbai | Regulated Life-Sciences Manufacturing | USFDA & WHO-PQ approved

NBGR is retained by a globally respected life-sciences manufacturer (established for over three decades) with exports to the USA, Europe, Japan, and China, to identify their next Vice President – Quality & Regulatory Affairs.

NThe Role

nSecond-in-command of the Quality & Regulatory function. Reporting to the Head of Quality & Regulatory, you will own day-to-day quality and regulatory operations across manufacturing, QC, QA, documentation, regulatory submissions, and supplier quality — and be groomed for succession.

NWhat you'll own

n- Execute and strengthen the QMS under EN ISO 13485, ISO 9001, USFDA 21 CFR 820, and WHO-PQ

N- Drive shop-floor QC across the full manufacturing cycle

N- Lead internal audits and front-line responses to USFDA, notified body, WHO, and customer audits

N- Own KPIs — batch rejection, RFT, deviation & CAPA closure, complaints, non-conformances

N- Drive regulatory submissions, product registrations, variations, renewals, and change notifications across USA, Europe, Japan, China, and RoW

N- Monitor regulatory intelligence;

assess impact of evolving regulations on product compliance

N- Ensure compliance with labelling, IFU, post-market surveillance,



and vigilance / adverse-event reporting

N- Partner with R&D; on Design Control, DHF/DMR, ISO 14971 risk management, and IQ/OQ/PQ validation

N- Run the supplier qualification, audit, and scorecard programme

N- Own end-to-end customercomplaint handling and CAPA closure

N- Lead, coach, and build depth in a 20+ member QA / QC / RA / Documentation team

NWhat we're looking for

N- 12–15 years in Quality & Regulatory Affairs within a USFDA / WHO-PQ approved manufacturing environment

N- Biologicals, biotech, pharma, or regulated life-sciences manufacturing background preferred

N- Proven experience as a lead responder in regulatory and customer audits

N- Hands-on experience with dossier preparation and regulatory submissions across US, EU, and RoW markets

N- Deep working knowledge of Design Control, CAPA, Change Control, Validation, PMS, and vigilance reporting

N- M.Sc. / M.Pharm in Chemistry, Microbiology, Biotechnology, or Life Sciences (Ph.D. / MBA / Six Sigma a plus)

N- Solid people leadership;

multi-site or multi-product exposure an added advantage

NWhat the client offers

NA defined career path with succession into the Head of Quality & Regulatory role for the right candidate, in a market-leading, globally exporting organisation.

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