What are the responsibilities and job description for the Regulatory Affairs Head US Director position at Biocon Biologics?
Role Summary
The ideal candidate for US AD regulatory affairs should have
- Proven US regulatory affairs experience
- Excellent leadership and communication skills,
- Negotiation & liaising experience with US FDA.
- Works with Biocon Biologics head of Canada RA to derive the global development strategy partnering with GRL (Global Regulatory Lead).
A 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 US regulatory strategy for approved products and products under development.
Lead the development and execution of a regulatory intelligence strategy for US
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 US 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 US product labelling and work with the GRL and labelling team to ensure core labels are appropriately complying to US label regulations
Partner with US 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
Salary : $180,000 - $190,000
