Placing the Regulatory Scientists and Drug Development Experts India's Pharma Industry Cannot Source Openly
The most critical talent in pharmaceuticals and biotech does not appear on job boards. A Head of Regulatory Affairs who has personally shepherded 50+ ANDA filings through the US FDA, a Quality Assurance Director who has led three US FDA inspections and resolved every 483 observation, a Head of Medicinal Chemistry with a patent portfolio spanning novel molecular entities — these professionals are found only through DCGI panel networks, NIPER alumni relationships, GMP audit communities, and years of built trust within India's pharmaceutical research ecosystem. That is the practice Gladwin brings to every pharma mandate.
1,400+
Pharma & Biotech professionals mapped
24+
Specialist mandates placed in 36 months
18
Regulatory and research institutions in our network
The Challenge
Why Pharma & Biotech Talent Is Uniquely Difficult to Source
Generic executive search methods fail in pharmaceuticals because the most capable specialists carry jurisdiction-specific regulatory expertise, are locked in long clinical study cycles, and operate in micro-pools that standard recruitment cannot penetrate.
Regulatory expertise is jurisdiction-specific and non-transferable
A Head of Regulatory Affairs who has filed ANDAs with the US FDA carries expertise that does not automatically transfer to EU EMA or CDSCO submissions. Each regulatory pathway demands specific dossier knowledge, agency relationships, and procedural familiarity. Identifying candidates with the exact jurisdictional match is a deep research problem, not a keyword search.
Clinical and bioanalytical talent is locked in long study cycles
Clinical Research Directors and Bioanalytical Scientists are often mid-study, bound by protocol obligations and sponsor contracts. They cannot move on short timelines, and their availability windows are dictated by trial phases. Engaging them requires understanding clinical trial calendars and planning six to twelve months ahead of the actual hire date.
Manufacturing QA heads with US FDA audit history are invisible
Plant-level Quality Assurance heads who have personally faced US FDA inspections and resolved 483 observations are a micro-pool in India. They rarely appear on LinkedIn, do not attend industry events, and are identified only through GMP audit networks and pharma manufacturing circles built over decades.
Coverage
Roles We Place — Across Every Pharma & Biotech Discipline
Our pharma practice covers the full spectrum of domain-specific, technical, and specialist roles — the mandates that demand genuine sector knowledge to identify, engage, and assess correctly.
Regulatory Affairs & Drug Approval
- Head of Regulatory Affairs — US FDA
- Regulatory Affairs Director — EU/EMA
- CDSCO Regulatory Specialist (Senior)
- Head of Dossier Management — CTD/eCTD
- Regulatory Strategy Lead — Biologics
- Head of Drug Master File (DMF) Operations
- Pharmacopoeial Affairs Manager
- Regulatory Affairs Lead — Medical Devices (CDSCO)
- Head of Global Regulatory Submissions
- Labelling & Artwork Compliance Head
Clinical Research & Medical Affairs
- Head of Clinical Operations — Phase III
- Principal Investigator Liaison Manager
- Clinical Data Management Head
- Biostatistician — Senior/Principal
- Head of Medical Affairs
- Pharmacoeconomics & HEOR Lead
- Medical Science Liaison Manager
- Clinical Pharmacology Lead
- Head of Bioanalytical Sciences
- Clinical Trial Supply Chain Manager
Manufacturing & QA (GMP)
- Head of Formulation Development — Oral Solids
- Plant Head — Injectable Manufacturing
- Quality Assurance Director — US FDA Compliance
- Head of Sterile Manufacturing
- Validation Head — Process & Cleaning
- Head of API Manufacturing
- Quality Control Director — Analytical Methods
- Head of Packaging Development
- OSD Manufacturing Head — High Potency
- GMP Compliance & Audit Manager
R&D & Drug Discovery
- Head of Medicinal Chemistry
- Lead Scientist — Biological Screening
- Head of Process Chemistry — API
- Formulation R&D Director
- Head of Analytical R&D
- Computational Chemistry Lead
- Head of Polymer & Novel Drug Delivery
- Enzymology & Protein Science Lead
- Head of Pre-clinical Pharmacology
- Impurity Profiling & Degradation Specialist
Pharmacovigilance & Safety
- Head of Pharmacovigilance — India
- Drug Safety Physician — Global PV
- Head of Signal Detection & Risk Management
- Aggregate Reporting Manager — PSUR/PBRER
- Head of PV Systems & Auditing
- Medical Reviewer — ICSR Processing
- Benefit-Risk Assessment Lead
- Head of PV Regulatory Intelligence
- Local Safety Officer — India/APAC
- PV Vendor & CRO Oversight Manager
Access
How We Reach Talent That Cannot Be Found by Search
Our pharma network has been built over a decade — not assembled from a database. Access is earned through relationships with regulatory scientists, manufacturing leaders, and clinical researchers across India's pharmaceutical ecosystem.
DCGI & CDSCO Panel Network
Direct engagement with professionals who have served on DCGI advisory panels and CDSCO review committees — providing access to India's most experienced regulatory affairs talent with first-hand knowledge of Indian drug approval pathways.
IDMA & OPPI Industry Associations
Active relationships with members of Indian Drug Manufacturers' Association (IDMA) and Organisation of Pharmaceutical Producers of India (OPPI), covering both Indian generics and MNC pharma leadership circles.
NIPER & IIT Pharma Alumni
Deep connections with alumni of National Institute of Pharmaceutical Education and Research (NIPER) campuses — Mohali, Hyderabad, Ahmedabad — and IIT pharmaceutical science departments, spanning M.Pharm and PhD graduates placed across India's pharma industry.
ICMR & Clinical Research Network
Engagement with Indian Council of Medical Research (ICMR) affiliated investigators, Ethics Committee members, and clinical trial site networks — essential for sourcing Clinical Operations and Medical Affairs leadership.
WHO-GMP & US FDA Audit Community
Relationships with quality professionals who have participated in WHO prequalification audits and US FDA CDER facility inspections — the most credible and scarce pool for Quality Assurance and Compliance leadership in Indian pharma.
Methodology
How We Validate Technical Depth — Not Just Credentials
A CV confirms a candidate has held a title. Our methodology confirms they have the domain depth the mandate requires. Every pharma search includes structured technical validation.
Regulatory dossier and filing track record
We verify the candidate's specific regulatory filings — number of ANDAs, DMFs, CTD submissions, CDSCO approvals personally managed. We confirm the jurisdictions filed in, approval rates, and any complete response letters or deficiency notices handled. Title does not equal filing depth.
GMP audit history and observation resolution
For manufacturing and QA roles, we review the candidate's direct experience with regulatory inspections — US FDA, WHO-GMP, MHRA, TGA. We assess the severity of observations faced (483s, warning letters) and the corrective actions personally led. Audit history is the most reliable quality leadership indicator.
Clinical trial phase and therapeutic area validation
For clinical research roles, we verify the specific trial phases managed (Phase I–IV), therapeutic areas covered, sample sizes handled, and regulatory submissions supported (IND, NDA, BLA). A Phase I oncology trial and a Phase III cardiovascular outcomes trial require fundamentally different competencies.
Publication and patent portfolio assessment
For R&D and drug discovery roles, we review the candidate's publication record in peer-reviewed journals, patent filings with Indian and international offices, and conference presentations. We assess whether their scientific contribution is original and whether it aligns with the client's pipeline and therapeutic focus.
Track Record
Mandates We Have Run — Anonymised
A selection of recent specialist placements across the pharmaceuticals and biotech sector. No client names are shared in line with our confidentiality policy.
Head of Regulatory Affairs — US FDA (ANDA)
Top-10 Indian generics company with 180+ ANDA approvals and active para-IV filings, seeking to strengthen US regulatory leadership.
Required a Head of Regulatory Affairs with minimum 50 personal ANDA filings, direct experience managing FDA complete response letters, and prior representation at FDA advisory committee meetings. Deep knowledge of OGD review processes mandatory. Placed within 55 days.
Quality Assurance Director — Injectable Plant
Large Indian CDMO operating a sterile injectable facility with US FDA and EU GMP approvals, supplying to 30+ regulated markets.
Mandate required a QA Director with at least 15 years in sterile manufacturing, personal experience leading 3+ US FDA inspections, demonstrated capability in resolving 483 observations, and prior exposure to pre-approval inspections for injectable ANDAs. Shortlist of 4 delivered in 44 days.
Head of Pharmacovigilance — India & APAC
Indian subsidiary of a top-20 global pharma company with an active portfolio of 60+ marketed products and 12 ongoing clinical trials in India.
Required a Head of PV with QPPV-equivalent experience, signal detection and risk management expertise, and demonstrated leadership in building PV systems from ground up for a multi-product portfolio. Prior CDSCO and MedWatch reporting experience essential. Placed within 48 days.
Start a Search
Share the specialist mandate. We will map India's pharma talent landscape in five working days.
Whether you need a Regulatory Affairs Director, a GMP Quality Head, or a Drug Discovery Lead — share the brief. Our pharma & biotech practice team will respond with an initial candidate landscape within 48 hours and a full research map within five working days.