Regulatory Strategy Associate Director
6 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 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.
J-18808-Ljbffr
#J-18808-Ljbffr
-
Regulatory Strategy Associate Director
16 ore fa
Roma, Italia Jefferson Wells Italia A tempo pienoRegulatory 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...
-
Director, Global Regulatory Strategy
16 ore fa
Roma, 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...
-
Global Regulatory Strategy Director
2 giorni fa
Roma, Italia GSK A tempo pieno 90.000 €A 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...
-
Global Regulatory Strategy Director
17 ore fa
Roma, 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...
-
Global Regulatory Strategy Director
16 ore fa
Roma, 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...
-
Global regulatory strategy director
6 ore fa
Roma, 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...
-
Global Regulatory Strategy Director
1 settimana fa
Roma, 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...
-
Global Regulatory Strategy Director
7 giorni fa
roma, 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...
-
Global Regulatory Strategy Director
7 giorni fa
Roma, 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...
-
Associate Director, Global Auditing
2 settimane fa
Roma, Italia Warman O'Brien A tempo pienoAssociate Director / Director – Global Pharma Leader – Italy (Remote / Hybrid) Our client, a globally renowned pharmaceutical company, is seeking a talented and experienced Associate Director / Director to join their high-impact team. Develop and review key trial documentation : protocols, SAPs, CSRs, publications, and more Provide expert statistical...
