What are the responsibilities and job description for the Regulatory Affairs Manager US position at Biocon Biologics?
The ideal candidate for US regulatory affairs should have a strong regulatory affairs background, excellent leadership and communication skills, negotiation & liaising with Health authorities.
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.
- Minimum 5 years relevant regulatory experience
- Responsible for assisting North American 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 fulfill 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 US and Canadian Regulatory Affairs 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 maintaining compliance of Canadian and US for products under development and marketed products in partnership with GRL and regulatory operations team (PSURS, annual reports, etc).
Salary : $140,000 - $150,000
