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 by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking.
We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients.
We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization in developed and emerging markets.
About the Role :
The ideal candidate for leading the Canada regulatory affairs should have a strong country specific regulatory affairs background, excellent leadership and communication skills, negotiation & liaising with Health Canada.
This position brings together Canada regulatory requirements to derive the global development strategy in partnering with GRL (Global Regulatory Lead).
Experience Required :
- Minimum 12 years relevant experience out of which more than 5 years of people manager role
- Responsible for Canada regulatory strategy of both products approved and products under development.
- 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.
- Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
- Supports development of Canada regulatory policy priorities, generates policy positions, develops action plans.
- 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 to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
- Assist North America head on product development strategy and participate in building the regulatory strategy.
- Drive the Canada product labelling and art work with the GRL and labelling team to ensure core labels are appropriately complying to regional label regulations
- Responsible for advices, LCM, PSUR and NDS submissions to Health Canada in partnership with GRL and regulatory operations team.
Educational Background :
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.
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