Position Summary
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.
Key Responsibilities
* Define 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, Pharmacovigilance, CMC, and Quality Assurance.
Qualifications
* Advanced 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 Attributes
* Experience 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 offer
A contract and salary proportional to the experience (seniority) of the successful candidate.
Job location
Milano / Siena / Zurich (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.
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