We are supporting a global consulting firm advising a large Indian pharmaceutical company (client name under NDA) on identifying and implementing AI / GenAI use cases across its R&D value chain. The initiative is focused on transforming R&D processes following the client's expansion into complex biologics and vaccines through a recent acquisition.

The consultant will serve as the senior R&D domain expert embedded within the consulting team, bringing deep industry expertise to assess current-state processes, identify transformation opportunities, and guide the prioritisation and implementation of AI-enabled solutions. The role will directly influence how the client unlocks efficiency, reduces process bottlenecks, and creates value across its R&D ecosystem.

Key Responsibilities

• Assess and validate current-state R&D and regulatory processes, workflows, and pain points across the pharmaceutical value chain.
• Identify and prioritise AI / GenAI use cases across R&D functions, including evaluating opportunities to build, buy, or partner for solutions.
• Provide domain expertise to support value assessment, impact estimation, and business case development for shortlisted AI initiatives.
• Act as a trusted interface with senior R&D, Regulatory Affairs, and Quality stakeholders to drive alignment and credibility.
• Support process redesign and solution validation during implementation by providing an R&D domain perspective.
• Collaborate closely with consulting and AI implementation teams to translate industry insights into actionable transformation roadmaps.

Your Background

• 15–20+ years of experience in pharmaceutical R&D and/or regulatory functions, including senior leadership roles.
• Strong expertise across the pharma R&D value chain, with experience in regulatory affairs, CMC, medical writing, and regulatory dossier lifecycle (ANDA / CTD / eCTD).
• Experience working with global regulatory frameworks, including familiarity with CDSCO, US FDA, and EMA requirements.
• Deep understanding of small-molecule generics and branded generics, with additional experience in complex biologics (recombinants, immunoglobulins, plasma derivatives, monoclonals) and/or vaccines preferred.
• Exposure to therapeutic areas such as women's health/fertility (ART-IVF) and injectables is a plus.
• Ability to engage senior R&D, Regulatory, and Quality stakeholders and translate business challenges into transformation opportunities.
• Comfortable working alongside consulting teams and AI/digital implementation teams; hands-on AI experience is beneficial but not mandatory.
• Life sciences educational background (M.Pharm, MSc, PhD, or equivalent); regulatory affairs qualifications are a plus.
• Preferred experience from leading pharma organisations such as Sun Pharma, Dr. Reddy’s, Cipla, Lupin, Zydus, Aurobindo, Torrent, Glenmark, Biocon, Serum Institute, or Bharat Biotech.

Other Info

• The project is currently at the proposal/pre-award stage, and the engagement is expected to commence in early August 2026, subject to client confirmation.
• The consultant will be based in Delhi-NCR or Mumbai, with regular onsite presence required at client R&D locations.
• Phase 1 will involve a 3–4 week diagnostic with significant onsite involvement (approximately 3–4 days/week), followed by a phased 6–8 month implementation support period with a more advisory engagement model.
• The consultant is expected to support both phases, with full-time/near full-time involvement during Phase 1 and part-time support during Phase 2.