Regulatory Strategy Associate Director

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.