Global Head Of Regulatory Affairs

Philogen S.P.A.; Prato; Ibrido; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading biotech company in Italy is looking for an experienced Global Head of Regulatory Affairs. The role requires a professional with a strong background in EMA and FDA pathways, exceptional leadership, and strategic capabilities in regulatory strategies. The candidate will guide the company's product development while ensuring compliance with global regulations. Remote work is possible, and the company offers a competitive salary based on experience.

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.
• Experience leading regulatory strategy for clinical-stage programs.

Mansioni

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

Conoscenze

Experience with EMA and FDA regulatory pathways

Leadership

Project management

Communication

Strategic mindset

Formazione

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

Strumenti

eCTD format

GCP

ICH guidelines

Descrizione del lavoro

Overview

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.

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.