Regulatory Strategy Associate Director

4 giorni fa

Lazio, Italia Jefferson Wells Italia A tempo pieno

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 ResponsibilitiesDefine and lead global regulatory strategies for development and marketed products, ensuring alignment with global regulatory lead, corporate objectives and regulatory expectationsProvide strategic input on clinical development plans, including study design, endpoints, and regulatory pathways to optimize approval timelinesLead preparation and review of major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and post-approval variations, ensuring scientific rigor and complianceRepresent the company in regulatory meetings and negotiations with health authorities, acting as the primary point of contact for strategic discussionsDrive risk assessment and mitigation strategies, anticipating regulatory challenges and developing proactive solutions to minimize impact on timelines and approvalsMentor and guide junior regulatory staff, fostering professional development and ensuring consistent application of regulatory best practicesCollaborate with senior leadership and cross-functional teams (Clinical, CMC, Safety, Commercial) to ensure integrated strategies and alignment across programsMonitor global regulatory trends and policy changes, providing strategic recommendations to senior management and influencing internal decision-makingContribute to process improvements and governance initiatives, ensuring efficiency and compliance in regulatory operationsMain RequirementsBachelor'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 submissionsDeep expertise in global regulatory frameworks, strategic planning, and health authority engagementStrong influencing and negotiation skills with regulatory agenciesAbility to lead cross-functional teams and manage complex projects in a matrix environmentEmployment typeFull-timeLocation: Milan, Lombardy, Italy.#J-*****-Ljbffr

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