Global Head of Regulatory Affairs

Emerald Marketing; Pavia; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

Une entreprise innovante dans le secteur pharmaceutique recherche un 'Head of Regulatory Affairs' pour diriger les efforts réglementaires au niveau mondial. Le candidat idéal devra posséder une expérience significative en développement clinique et une solide connaissance des réglementations EMA et FDA. Ce rôle est essentiel pour assurer la conformité réglementaire tout au long du cycle de vie des produits, des essais cliniques à l'autorisation de mise sur le marché.

Servizi

Salaire compétitif

Équilibre travail-vie personnel

Competenze

• Au moins 10 ans d'expérience en affaires réglementaires.
• Expérience avérée dans les interactions avec EMA et FDA.
• Compétences en leadership et gestion d'équipe.

Mansioni

• Définir et mettre en œuvre des stratégies réglementaires globales.
• Préparer et soumettre des documents réglementaires tels que INDs et CTAs.
• Gérer les interactions avec les agences réglementaires.

Conoscenze

Connaissance approfondie des réglementations EMA et FDA

Gestion de projet

Communication

Anticipation des tendances réglementaires

Formazione

PhD, PharmD, MD ou MSc en sciences de la vie

Strumenti

Format eCTD

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 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.

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