Manager / Senior Manager
Medical Affairs (NCE)

About the Role

As Manager / Senior Manager – Medical Affairs (NCE) at our Whitefield, Bangalore office, you will lead end-to-end Medical Affairs and Translational Medicine activities for multiple new chemical entities across regulatory submissions. This is a senior scientific role requiring deep expertise in late-stage NCE development, clinical study design, and regulatory documentation for FDA, EMA, and CDSCO.

You will work in a fast-paced biotech environment that values scientific rigour, operational excellence, and a high degree of ownership. The role involves close collaboration with Clinical Operations, Biostatistics, and Regulatory Affairs teams.

Key Responsibilities

• Lead end-to-end Medical Affairs and Translational Medicine for multiple NCEs across regulatory submissions (FDA, EMA, CDSCO)
• Design comprehensive clinical development plans aligned with regulatory strategy and commercial objectives
• Oversee clinical study execution from protocol design through data review and final reporting
• Author and review regulatory documents including clinical protocols, briefing books, IND/CTA/NDA/BLA/MAA materials, and clinical summaries
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, and Commercial teams
• Conduct data reviews and interpret clinical data to support regulatory submissions and scientific communications
• Develop and deliver MSL training materials and scientific communication tools for medical and commercial teams
• Monitor the clinical landscape in relevant therapeutic areas and provide strategic input on product positioning
• Ensure all activities are conducted in compliance with ICH-GCP, FDA, EMA, and CDSCO guidelines

Qualifications & Experience

• MD, PhD, or PharmD from a recognised institution; combined clinical and research training preferred
• 8–10 years of experience in pharma/biotech sectors with significant late-stage NCE development background
• Track record of successful product launches and regulatory submissions (IND/CTA/NDA/BLA/MAA)
• In-depth knowledge of GCP, FDA, EMA, and CDSCO regulatory guidelines
• Hands-on experience with interventional clinical study design, execution, and oversight
• ICH-GCP and protocol design proficiency; experience with Phase II/III clinical trial management
• Strong scientific writing and communication skills — ability to author protocols, briefing documents, and regulatory dossiers
• Preferred therapeutic area experience: Ophthalmology, Hepatology, Autoimmune, Anti-inflammatory
• Cross-functional leadership experience with ability to drive alignment across diverse teams