Regulatory Strategy Associate Director

2 settimane fa

Milano, Lombardia, Italia Jefferson Wells Italia A tempo pieno

Jefferson Wells 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 engagemeny

● Strong influencing and negotiation skills with regulatory agencies

● Ability to lead cross-functional teams and manage complex projects in a matrix environment

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