Head of Regulatory India

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 Biogens incountry regulatory strategy submissions and R&D compliance activities across Biogens portfolio in India. Acts as Biogens senior regulatory interface with Indian Health Authorities providing regulatory guidance in a complex and evolving environment. Supports the development of innovative regulatory strategies for the portfolio which includes rare and high unmetneed 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 Biogens 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 ultrarare diseases including justification of limited patient populations use of foreign clinical data and leadership of benefitrisk 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 regulatory submissions for new products and lifecycle changes including labelling CMC GMP import registrations and variations to ensure strategic contribution to pipeline development timely approvals and product continuity in collaboration for local regional and global regulatory CMC PO&T and Quality stakeholders. Accountable for management of the local label packaging and artwork changes.

4. Regulatory Intelligence Interpretation & Driving Policy; Monitors and interprets evolving Indian regulatory requirements provides impact assessments to stakeholders and contributes to central regulatory intelligence activities. Progresses Biogens policy priorities.

5. Promotional Material & Compliance Oversight; Ensures review and approval of local promotional and nonpromotional materials in compliance with Indian legislation & guidance and local label.

6. Matrix Leadership & External Representation; Builds effective crossfunctional and external relationships represents Biogen with regulatory authorities and industry bodies as required and influences regulatory teams and partners within a matrixed organization.

Qualifications:

• Minimum 7 years experience in Regulatory Affairs; Demonstrated expert regional regulatory thinking and risk assessment capability Broad working knowledge of Indian pharmaceutical legislation including direct engagement with CDSCO / DCGI
• Experience in interpretation and application of regulations guidelines policy statements and influencing/advising the business accordingly; Demonstrates consistent judgement
• Experience in interfacing with relevant regulatory authorities. Foster effective positive interactions with regulatory agencies and corporate partners; Ability to assimilate new knowledge rapidly and deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound
• Demonstrated experience in rare disease or high unmet-need product development and registration including justifying limited patient populations and leveraging foreign clinical data.
• Strong linkage of development strategies with long-term commercialization considerations.
• Ideal candidate will be customer focused with proven leadership and interpersonal skills cultural awareness high emotional intelligence and collaborative decision making approach
• Must build relationships throughout and across the organization whilst operating remotely; Requires exceptional organizational and project management skills with an ability to set clear goals align priorities and lead multiple tasks/activities.
• Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
• Ability to impact and influence the decisions of a team external parties and higher-level groups; Effective presentation skills.
• Confident and proficient at communication with relevant external bodies and internally at all levels; Strong English language communication skills.
• Prior experience of people management and development preferred.
• Indian citizen with scientific degree (e.g. pharmacy medicine life sciences) with eligibility to engage with Indian Health Authorities.

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.