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Global Head of Regulatory Affairs
2 settimane fa
**Location: Siena - Italy, Zurich - Switzerland**
**Department: Clinical**
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 Summary**
**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, Pharmaco Vigilance, 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**
**Job location**
- Milano/Siena (remote work possible)
