Head of Regulatory Compliance

beBeeRegulatory; Milano; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

beBeeRegulatory recherche un expert en affaires réglementaires pour diriger la fonction réglementaire et assurer la conformité avec les exigences mondiales. Ce rôle clé implique de définir la stratégie réglementaire tout au long du développement du produit, nécessitant une expertise dans les voies EMA et FDA ainsi qu'une expérience significative dans l'industrie. Les candidats doivent avoir un diplôme avancé en sciences de la vie et au moins 10 ans d'expérience.

Competenze

• Minimum 10 ans d'expérience en affaires réglementaires dans l'industrie pharmaceutique ou biotech.
• Connaissance des formats eCTD, GCP et des réglementations des essais cliniques.
• Expérience en oncologie ou développement de médicaments immunologiques est un plus.

Mansioni

• Définir et mettre en œuvre des stratégies réglementaires globales pour le développement clinique.
• Préparer et soumettre des documents réglementaires, y compris INDs, CTAs, et MAAs.
• Gérer les interactions avec les agences EMA et FDA.

Conoscenze

Interactions EMA et FDA

Gestion de projet

Communication

Analyse stratégique

Formazione

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

Strumenti

eCTD

Descrizione del lavoro

Philogen S.p.A. is seeking a highly motivated and qualified Regulatory Affairs Expert to lead our regulatory function and ensure compliance with global regulatory requirements.

This key leadership role is pivotal in shaping and executing our regulatory strategy across all stages of product development, from early clinical trials to market authorization.

The successful candidate will bring deep expertise in EMA and FDA regulatory pathways, scientific advice procedures, and eCTD submissions.

• 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

• Education : Advanced degree (PhD, PharmD, MD, or MSc) in a life sciences discipline.
• Experience : Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
• Skills : Proven track record of successful interactions with both EMA and FDA across multiple phases of development.
• Knowledge : Strong knowledge of eCTD format, GCP, ICH guidelines, and global clinical trial regulations.
• Leadership : Excellent leadership, communication, and project management skills.
• Strategic Mindset : 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.

Our company offers a contract and salary proportional to the experience (seniority) of the successful candidate.

We welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.