PPhilogen S.p.A. would like to hire a highly motivated and qualified bGlobal Head of Regulatory Affairs /bto lead our regulatory function and ensure compliance with global regulatory requirements. This is a key leadership role responsible for developing and executing regulatory strategies that support the company’s product development and commercialization goals. /ppbr/ppbPosition Summary /b /ppWe are seeking a highly experienced and strategic bGlobal Head of Regulatory Affairs /b to lead our global regulatory efforts, with a particular focus on clinical development programs. The successful candidate will bring deep expertise in EMA and FDA regulatory pathways, scientific advice procedures, and eCTD submissions. This role is pivotal in shaping and executing our regulatory strategy across all stages of product development, from early clinical trials to market authorization. /ppbr/ppbKey Responsibilities /b /pulliDefine and implement global regulatory strategies to support clinical development and product registration. /liliLead the preparation and submission of regulatory documents, including INDs, CTAs, MAAs, NDAs, amendments, and responses to health authority questions. /liliManage and coordinate all aspects of EMA and FDA interactions, including scientific advice, pre-IND/IMPD meetings, and advisory committee preparation. /liliEnsure timely and compliant preparation of dossiers in eCTD format. /liliMaintain up-to-date knowledge of global regulatory requirements, trends, and best practices. /liliRepresent the company in direct communications and meetings with regulatory agencies. /liliCollaborate closely with cross-functional teams including Project Management, Medical Team, Pharmaco Vigilance, CMC, and Quality Assurance. /li /ulpbr/ppbQualifications /b /pulliAdvanced degree (PhD, PharmD, MD, or MSc) in a life sciences discipline. /liliMinimum 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry. /liliProven track record of successful interactions with bboth EMA and FDA /b across multiple phases of development. /liliStrong knowledge of beCTD format /b, GCP, ICH guidelines, and global clinical trial regulations. /liliExperience leading regulatory strategy for bclinical-stage /b programs is essential. /liliExcellent leadership, communication, and project management skills. /liliStrategic mindset with the ability to anticipate regulatory trends and proactively manage risks. /li /ulpbr/ppbPreferred Attributes /b /pulliExperience in oncology or immunology drug development. /liliPrior involvement in health authority advisory meetings and global regulatory submissions from early-phase to post-marketing. /liliFamiliarity with orphan drug designation, fast track, and breakthrough therapy programs is a plus. /li /ulpbr/ppbWe offer /b /ppA contract and salary proportional to the experience (seniority) of the successful candidate. /ppbr/ppbJob location /b /ppMilano/Siena/Zurich (remote work possible) /ppbr/ppWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. /p