Regulatory Strategy Associate Director
Descrizione dell'offerta
The Regulatory Strategy Associate Director leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities.
Main Responsibilities
Define and lead global regulatory strategies for development and marketed products, ensuring alignment with global regulatory lead, corporate objectives and regulatory expectations.
Provide strategic input on clinical development plans, including study design, endpoints, and regulatory pathways to optimize approval timelines.
Lead preparation and review of major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and post-approval variations, ensuring scientific rigor and compliance.
Represent the company in regulatory meetings and negotiations with health authorities, acting as the primary point of contact for strategic discussions.
Drive risk assessment and mitigation strategies, anticipating regulatory challenges and developing proactive solutions to minimize impact on timelines and approvals.
Mentor and guide junior regulatory staff, fostering professional development and ensuring consistent application of regulatory best practices.
Collaborate with senior leadership and cross-functional teams (Clinical, CMC, Safety, Commercial) to ensure integrated strategies and alignment across programs.
Monitor global regulatory trends and policy changes, providing strategic recommendations to senior management and influencing internal decision-making.
Contribute to process improvements and governance initiatives, ensuring efficiency and compliance in regulatory operations.
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