Assistant Manager / Deputy Manager
Medical Affairs (NCE)

About the Role

As Assistant Manager / Deputy Manager – Medical Affairs (NCE) at our Whitefield, Bangalore office, you will support end-to-end Medical Affairs and Translational Medicine activities for new chemical entities. You will contribute to clinical development planning, assist in the design and execution of clinical studies, and help prepare regulatory documents for FDA, EMA, and CDSCO submissions.

This is an excellent opportunity for an early-career medical or scientific professional to build deep expertise in NCE development within a fast-paced biotech environment that values scientific rigour and operational excellence.

Key Responsibilities

• Support end-to-end Medical Affairs and Translational Medicine activities for multiple NCEs across regulatory submissions
• Assist in developing clinical development plans and contribute to study design and protocol preparation
• Support clinical study execution — coordinate study activities, monitor data, and assist with data reviews
• Contribute to authoring regulatory documents including clinical protocols, briefing books, IND/CTA materials, and clinical summaries
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs
• Support preparation of MSL training materials and scientific communication tools
• Assist in monitoring the clinical and scientific landscape in relevant therapeutic areas
• 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 is a strong advantage
• 1–3 years of experience in pharma/biotech sectors; exposure to NCE development or clinical research preferred
• Knowledge of GCP, FDA, EMA, and/or CDSCO regulatory guidelines
• Understanding of interventional clinical study design and ICH-GCP principles
• Strong scientific writing skills — ability to contribute to protocols, briefing documents, and regulatory summaries
• Preferred therapeutic area interest: Ophthalmology, Hepatology, Autoimmune, Anti-inflammatory
• Experience with or exposure to IND/CTA/NDA/BLA/MAA documentation is an advantage
• Strong communication skills and ability to work effectively in cross-functional teams