Regulatory Affairs Director

About the company :

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first.

Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking.

We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization.

Job Description :

• ideal candidate for EU regulatory affairs should have
• Proven EU regulatory affairs experience
• Excellent leadership and communication skills,
• Negotiation & liaising experience with EU FDA.
• Works with Biocon Biologics head of RA to derive the global development strategy partnering with GRL (Global Regulatory Lead).
• postdoctoral / doctoral / Masters degree in life sciences, pharmacy or related field is typically required as well as experience in regulatory strategy, operations, labelling development, ad promo review and submissions in the biologics / biosimilar industry.
• Minimum 15 years relevant experience out of which more than 10 years of people manager role
• Responsible for all aspects of the EU regulatory strategy for approved products and products under development.
• Lead the development and execution of a regulatory intelligencestrategy for EU
• Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have an impact on BBL portfolio and access strategies.
• Leads the development of EU regulatory policy priorities, generates policy positions, develops action plans and influence the agency FDA interactions and Trade organizations.
• Will serve as the point of contact for the Agency’s interactions and act as local agent / local regulatory representative.
• Support GRL on product development strategy and participate in cross functional project team meetings to align on the regulatory strategies across the regions
• Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for BLA submission
• Drive the EU product labelling and work with the GRL and labelling team to ensure core labels are appropriately complying to US label regulations
• Partner with EU commercial team and ad promo team to ensure the regulatory compliance
• Participate in the agency meetings to present BBL position and negotiate on BBL positions by establishing network with the agency as required.

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.