Global Head Of Regulatory Affairs

Da remoto: Remoto Philogen S.P.A. would like to hire a highly motivated and qualified Global Head of Regulatory Affairs to 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.Position SummaryWe are seeking a highly experienced and strategic Head of Regulatory Affairs 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.Key ResponsibilitiesDefine and implement global regulatory strategies to support clinical development and product registration.Lead the preparation and submission of regulatory documents, including INDs, CTAs, MAAs, NDAs, amendments, and responses to health authority questions.Manage and coordinate all aspects of EMA and FDA interactions, including scientific advice, pre-IND/IMPD meetings, and advisory committee preparation.Ensure timely and compliant preparation of dossiers in eCTD format.Maintain up-to-date knowledge of global regulatory requirements, trends, and best practices.Represent the company in direct communications and meetings with regulatory agencies.Collaborate closely with cross-functional teams including Project Management, Medical Team, Pharmaco Vigilance, CMC, and Quality Assurance.QualificationsAdvanced degree (PhD, PharmD, MD, or MSc) in a life sciences discipline.Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.Proven track record of successful interactions with both EMA and FDA across multiple phases of development.Strong knowledge of eCTD format, GCP, ICH guidelines, and global clinical trial regulations.Experience leading regulatory strategy for clinical-stage programs is essential.Excellent leadership, communication, and project management skills.Strategic mindset with the ability to anticipate regulatory trends and proactively manage risks.Preferred AttributesExperience in oncology or immunology drug development.Prior involvement in health authority advisory meetings and global regulatory submissions from early-phase to post-marketing.Familiarity with orphan drug designation, fast track, and breakthrough therapy programs is a plus.We offerA contract and salary proportional to the experience (seniority) of the successful candidate.Job locationMilano/Siena (remote work possible)We 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. ▷ [24h Rimaste] Global Head of Regulatory Affairs Philogen S.p.A. would like to hire a highly motivated and qualified Global Head of Regulatory Affairs to lead our regulatory function and ensure compliance with global regulatory requirements. This is a key leadership role responsible for developing and executing regulatory Head of Regulatory Affairs The Green Recruitment Company Philogen S.p.A. would like to hire a highly motivated and qualified Head of Regulatory Affairs to lead our regulatory function and ensure compliance with global regulatory requirements. This is a key leadership role responsible for developing and executing regulatory Head of Regulatory Affairs Social network you want to login/join with:Philogen S.p.A. would like to hire a highly motivated and qualified Head of Regulatory Affairs to lead our regulatory function and ensure compliance with global regulatory requirements. This is a key leadership role responsible Head Of Regulatory Strategy Regulatory affairs is a critical function in the life sciences industry, requiring professionals with strong leadership and strategic skills. A head of regulatory affairs plays a pivotal role in ensuring compliance with global regulatory requirements and supporting product Head of Medical Affairs - Italy DescriptionHead of Medical Affairs -ItalyAbout AstellasAt Astellas we are a progressive health partner, delivering value and outcomes where needed.We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where Global Head of Accounting Finatal The Role: Group Financial ControllerLocation: Milan, ItalyThe Salary: €70,000- €90,000 bonusReference: EG1002Finatal is partnered with a high-growth private equity-backed technology company headquartered in Milan. Fresh off a €50M Series B and scaling rapidly Head of Regulatory Compliance beBeeRegulatory Philogen S.p.A. is seeking a highly motivated and qualified Regulatory Affairs Expert to lead our regulatory function and ensure compliance with global regulatory requirements.This key leadership role is pivotal in shaping and executing our regulatory strategy across all Global Head of External Communications, Leading Global Pharmaceutical Company, Milan Hanson Search Shape the Global Reputation of a Leading Healthcare OrganisationA prominent, innovation-led pharmaceutical group with a growing international presence is seeking an experienced and strategic Global Head of External Communications to lead its global reputation and Head of Global Standards and Compliance (GSC), Base Building Standards & Compliance Amazon EU SARL (Italy Branch) - D68 Social network you want to login/join with:Head of Global Standards and Compliance (GSC), Base Building Standards & Compliance, Milancol-narrow-leftClient:Amazon EU SARL (Italy Branch) - D68Location:Job Category:Other-EU work permit Global Head Of Accounting Ameresco Milan Permanent Negotiable Wealth Management PR/545791_1747402287 A major player in the global financial services industry, is looking for a Head of Accounting, who will play a critical role in supporting the Group's strategic initiatives, including M&A activities, Regulatory Affairs Specialist Quanta System Spa WHO WE AREAs a laser technology company, we innovate to improve life quality of people with one consistent belief: creating new perspectives for future generations by evolving with our most inner attitudes.Cause there is always a way to make life better. And this way finds Regulatory Affairs Study Start Up Coordinator CTI Clinical Trial Services, Inc Regulatory Affairs Study Start Up Coordinator (M / F / d)Job Purpose / SummaryThis position is responsible for providing regulatory administrative support to the Regulatory Specialists in Italy. Duties include entry and tracking of trial-related regulatory Government and Regulatory Affairs Executive_Italy Gaming Labs International Government and Regulatory Affairs Executive_ItalyBologna, Metropolitan City of Bologna, Italy Req 1346Tuesday, March 25, 2025Government and Regulatory Affairs Executive - EMEIAWhile providing integrity to the casino and gambling industry for over 30 years, GLI has Regulatory Affairs Officer IQVIA LLC Regulatory Affairs Officer page is loadedRegulatory Affairs OfficerApply locations Milan, Italy time type Full time posted on Posted 2 Days Ago time left to apply End Date : July 15, 2025 (4 days left to apply) job requisition id R1455565Job OverviewUnder general Regulatory Affairs Lead- FSP Thermo Fisher Scientific Join to apply for the Regulatory Affairs Lead- FSP role at Thermo Fisher ScientificContinue with Google Continue with Google1 week ago Be among the first 25 applicantsJoin to apply for the Regulatory Affairs Lead- FSP role at Thermo Fisher ScientificGet AI-powered Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - Italian & E[] Ergomed Company DescriptionPrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all Head of Market Access Pharma Point Global Head of Corporate Communications – Tech | Milan Hanson Search Lead Global Communications for a High-Growth Technology InnovatorOur client, a rapidly scaling global technology company with a European headquarters in Milan, is looking for a visionary and strategic Global Head of Corporate Communications to lead its global reputation ▷ (Candidati in 3 Minuti) Global Head of Accounting Finatal The Role: Group Financial ControllerLocation: Milan, ItalyThe Salary: €70,000- €90,000 bonusReference: EG1002Finatal is partnered with a high-growth private equity-backed technology company headquartered in Milan. Fresh off a €50M Series B and scaling rapidly across Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - Italian, Fr[] Ergomed Company DescriptionPrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all J-18808-Ljbffr

Location: Milano, Lombardia, IT

Posted Date: 8/18/2025