Global Head of Regulatory Affairs

Saleslogic; Milano; Remoto; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Global Head of Regulatory Affairs to lead regulatory strategies and ensure compliance with EMA and FDA requirements. The ideal candidate will have over 10 years of experience in Regulatory Affairs and a strong background in clinical development. This pivotal leadership role entails managing regulatory submissions and collaborating with cross-functional teams to drive product development.

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 across multiple phases of development.
• Experience leading regulatory strategy for clinical-stage programs is essential.

Mansioni

• 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.
• Coordinate all aspects of EMA and FDA interactions, including scientific advice.

Conoscenze

Regulatory strategy

Project management

Communication

Leadership

Knowledge of eCTD format

Anticipating regulatory trends

Formazione

Advanced degree (PhD, PharmD, MD, or MSc) in a life sciences discipline

Descrizione del lavoro

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 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, 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.

Equal Employment Opportunity

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.