Regulatory Strategy Associate Director
22 ore fa
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-timeLocationMilan, Lombardy, Italy.J-*****-Ljbffr#J-*****-Ljbffr
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Regulatory Strategy Associate Director
22 ore fa
Lazio, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate DirectorJefferson 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...
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Director, Global Regulatory Strategy
22 ore fa
Lazio, Italia Jefferson Wells Italia A tempo pienoA leading biopharmaceutical company is seeking a Regulatory Strategy Associate Director to lead global regulatory strategies for complex development programs.The role involves defining regulatory pathways, guiding submission preparations, and engaging with health authorities.Candidates should possess 8-10 years of experience in Regulatory Affairs, strong...
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Global Regulatory Strategy Director
22 ore fa
Lazio, Italia Gsk A tempo pienoA global healthcare company based in Italy is seeking a Director for Global Regulatory Affairs to lead the development and execution of regulatory strategies. This pivotal role requires extensive experience in regulatory affairs and a proven track record in leading development and submission activities. The successful candidate will collaborate with various...
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Global Regulatory Strategy Director
1 settimana fa
Lazio, Italia Gsk A tempo pienoA global biopharma company is seeking a Director of Global Regulatory Affairs to develop and execute regulatory strategies for innovative medicines and vaccines. This role requires a Bachelor's degree, extensive experience in regulatory affairs, and strong leadership abilities. The ideal candidate should have a proven track record in managing regional...
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Associate Director Biostatistics
2 settimane fa
Lazio, Italia Warman O'Brien A tempo pienoAssociate Director / Director – Global Pharma Leader – Italy (Remote / Hybrid)Are you ready to take the next big step in your biostatistics career?Our client, a globally renowned pharmaceutical company, is seeking a talented and experienced Associate Director / Director to join their high-impact team.If you thrive in a collaborative, fast-paced...
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Associate Director, Biostatistics
22 ore fa
Lazio, Italia Iqvia A tempo pienoJob Overview We are looking for an Associate Director, Biostatistics to manage a team of Biostatistics staff.In addition, to : Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.Serve as a resource for the department, ensuring...
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Director Of Regulatory Affairs
2 settimane fa
Lazio, Italia Buscojobs IT C2 A tempo pienoThe Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...
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Associate Director, Biostatistics
2 settimane fa
Lazio, Italia Iqvia A tempo pienoOverviewJob Overview :We are looking for an Associate Director, Biostatistics to manage a team of Biostatistics staff.In addition, to :Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.Serve as a resource for the department,...
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Associate Director, Biostatistics
6 giorni fa
Lazio, Italia Iqvia A tempo pienoJob OverviewWe are looking for an Associate Director, Biostatistics to manage a team of Biostatistics staff.In addition, to : Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.Serve as a resource for the department, ensuring...
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Associate Director, Biostatistics
6 giorni fa
Lazio, Italia Iqvia A tempo pienoJob Overview We are looking for an Associate Director, Biostatistics to manage a team of Biostatistics staff.In addition, to : Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.Serve as a resource for the department, ensuring...
