Head of Regulatory Affairs

Philogen S.p.A.; Varese; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

Philogen S.p.A. is seeking a highly qualified Head of Regulatory Affairs to lead their global regulatory function. This key leadership role involves defining regulatory strategies, managing submissions to EMA and FDA, and ensuring compliance across product development stages. Candidates should possess a strong background in regulatory affairs and exceptional leadership skills, particularly in the biotech or pharmaceutical sectors.

Competenze

• Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
• Proven track record of successful interactions with EMA and FDA.
• Strong knowledge of eCTD format, GCP, ICH guidelines, and global clinical trial regulations.

Mansioni

• Define and implement global regulatory strategies to support clinical development and product registration.
• Lead the preparation and submission of regulatory documents including INDs and MAAs.
• Ensure timely and compliant preparation of dossiers in eCTD format.

Conoscenze

Leadership

Communication

Project Management

Regulatory Strategy

Formazione

PhD, PharmD, MD, or MSc in a life sciences discipline

Descrizione del lavoro

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 strategies that support the company’s product development and commercialization goals.

Position Summary

We 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 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

A contract and salary proportional to the experience (seniority) of the successful candidate.

Job location

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.