What are the responsibilities and job description for the Director/Sr. Director of Global Regulatory Strategy position at Fortvita Biologics?
The Director / Sr. Director of Global Regulatory Strategy is a key leadership role responsible for developing and executing innovative global strategies to ensure successful market approval for products across major regions including the US, EMA, Japan, Australia, and Canada. This position leads the Global Regulatory Team and acts as the primary regulatory liaison with product development and support teams. The ideal candidate will not only mitigate regulatory risks proactively but also ensure compliance with global regulations while fostering a collaborative team environment.
- Lead the Global Regulatory Team in crafting creative strategies that align with regulatory requirements to meet business goals for both development and marketed products.
- Collaborate with a cross-functional team and regulatory professionals to ensure strategic messaging is clear in global regulatory submissions and responses to agency inquiries.
- Accountable for meeting corporate objectives and being a key driver of regulatory policy and strategy for designated products.
- Continuously prepare and update regulatory risk assessments and mitigation strategies, communicating these plans to relevant stakeholders.
- Work independently while also collaborating closely with the GRA Head, and may lead various regulatory and company initiatives.
- Influence the development of regulations and guidance by analyzing legislation and providing clear insights to the organization, ensuring accountability worldwide for assigned products.
- Make critical decisions related to work processes, operational plans, and schedules to achieve program objectives set by senior management.
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