Global Head of Regulatory Affairs

Philogen S.p.A.; Torino; Ibrido; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A biotechnology company is seeking a Global Head of Regulatory Affairs in Italy to lead regulatory strategies for clinical development programs. The ideal candidate will have a PhD in life sciences, over 10 years of experience in the pharmaceutical industry, and a proven track record of successful regulatory submissions. This role involves direct interactions with EMA and FDA and may offer remote work options.

Servizi

Competitive salary based on experience

Remote work options

Competenze

• Minimum 10 years of experience in Regulatory Affairs.
• Proven track record with EMA and FDA.
• Strong knowledge of GCP and ICH guidelines.

Mansioni

• Define and implement global regulatory strategies.
• Lead regulatory document submissions.
• Manage EMA and FDA interactions.

Conoscenze

Regulatory strategy implementation

EMA and FDA interactions

eCTD submissions

Leadership skills

Project management skills

Communication skills

Formazione

Advanced degree in life sciences

Strumenti

eCTD format

Descrizione del lavoro

Position Summary

We are seeking a highly experienced and strategic Global 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 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.