We are hiring a Head of Regulatory for our Biogen India entity. This is one of the first roles to set-up a newly created entity. The RA Head will be accountable for the leadership and execution of Biogen’s in‑country regulatory strategy, submissions and R&D; compliance activities across Biogen’s portfolio in India. Acts as Biogen’s senior regulatory interface with Indian Health Authorities, providing regulatory guidance in a complex and evolving workplace. Supports the development of innovative regulatory strategies for the portfolio which includes rare and high unmet‑need diseases, including use of foreign clinical data and management of limited precedent. Partners with Country, Regional, and Global stakeholders to support clinical development, commercialization and lifecycle management in India.

Responsiblities include:

1. Regulatory and Health Authority Leadership; Leads and executes upon the agreed India regulatory strategy and acts as Biogen’s senior regulatory interface with CDSCO/DCGI and Subject Expert Committees,



including preparation of briefing books and management of regulatory queries. Provides regulatory guidance and advice to Country Commercial Head/GM and Global Regulatory leadership.

2. Rare Disease & Innovative Product Registration; Develops and executes regulatory strategies for Biogen portfolio in India which includes rare and ultra‑rare diseases, including justification of limited patient populations, use of foreign clinical data and leadership of benefit–risk discussions where local precedent is limited. Maintains comprehensive knowledge and apply national requirements & guidelines for activities such as early access programs, Phase II, III and IV or market access trials. Provides regulatory advice for Clinical Trial Applications in India, where requested, ensuring compliance with national guidelines and alignment of clinical development with future commercialisation considerations.
3. Submission Delivery & Lifecycle Management; Drives regu

📌 Head of Regulatory (New Delhi)
🏢 Biogen
📍 New Delhi