Regulatory Affairs, Noram Jobs

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.

The ideal candidate for leading the North America regulatory affairs should have a strong country specific regulatory affairs background, excellent leadership and communication skills, negotiation & liaising with Health Noram. This position brings together Noram regulatory requirements to derive the global development strategy in partnering with GRL (Global Regulatory Lead).

A 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 and biosimilar industry.

• Keep abreast of internal and external changes, trends, developments and other dynamic relevant to the regulatory environment that may have an impact on BBL products.
• Minimum 12 years relevant experience out of which more than 5 years of people manager role
• Responsible to fulfil the module 1 requirements at local level such as Drug establishment licences, annual maintenance of DEL, test sites, NERBY submissions and supervision on pharmacovigilance
• Responsible for advices, LCM, PSUR and NDS submissions to Health Nor Am in partnership with GRL and regulatory operations team.
• Assist North America head on product development strategy and participate in building the regulatory strategy.
• Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
• Drive the Noram product labelling and art work with the GRL and labelling team to ensure core labels are appropriately complying to regional label regulations
• Responsible for Noram regulatory strategy of both products approved and products under development.
• Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
• Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.

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.