Job Location : San Diego,CA, USA
Director of Global Regulatory Affairs Strategy
About the Company
A leading biopharmaceutical organization recognized globally for its innovative solutions.
Industry Biotechnology
Type Public Company
Founded 1988
Employees 501-1000
Categories
Specialties
Business Classifications
About the Role
We are looking for a dynamic Director of Global Regulatory Affairs Strategy to join our international team. In this influential role, you will spearhead the development of comprehensive global regulatory strategies across our product portfolio, from initial stages through to approval and beyond. Collaborating closely with the Head of Regulatory Affairs and the Global Regulatory leadership team, you will leverage your deep understanding of regulatory frameworks, policies, and agency expectations.
As a strategic partner, you will provide essential regulatory insights and perspectives, facilitating cross-functional decision-making and enhancing our regulatory strategies for product development and lifecycle management. The ideal candidate will possess a BS/BA in a relevant scientific discipline, with an advanced degree preferred, and a minimum of 12 years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs.
Key qualifications include significant leadership experience, strong negotiation skills, and a proven ability to manage complex, multifaceted projects. You should be skilled in fostering relationships and building networks, with a proactive and transparent approach to your work. Additionally, your capabilities in conducting expert analyses and providing recommendations on regulatory risks, pathways, and policy shifts will be essential in this role.
Hiring Manager Title Head of Regulatory Affairs
Travel Percent Less than 10%
Functions