Regulatory Strategy Associate Director
Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company.
The candidate 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

Main Requirements

Bachelor’s or Master’s in Life Sciences, Pharmacy, or related field (advanced degree preferred)
8–10+ years in Regulatory Affairs with proven leadership in global strategy and major submissions
Deep expertise in global regulatory frameworks, strategic planning, and health authority engagement
Strong influencing and negotiation skills with regulatory agencies
Ability to lead cross-functional teams and manage complex projects in a matrix environment

Employment type
Full-time
Location: Milan, Lombardy, Italy.
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