Global Head Of Regulatory Affairs

Sanoma Learning; Milano; Remoto; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Sanoma Learning sta cercando un 'Global Head of Regulatory Affairs' motivato e qualificato per guidare la funzione regolatoria dell'azienda. In questo ruolo chiave, sarai responsabile dello sviluppo e dell'esecuzione delle strategie regolatorie globali, assicurando la conformità con i requisiti normativi internazionali. È necessaria una forte competenza nelle interazioni con enti normativi e conoscenze approfondite nel settore farmaceutico per supportare lo sviluppo dei prodotti dall'inizio alla commercializzazione. L'azienda offre condizioni e compensi in linea con l'esperienza del candidato.

Competenze

• Almeno 10 anni di esperienza in affari regolatori nel settore farmaceutico o biotech.
• Track record di interazioni efficaci con EMA e FDA.
• Forte conoscenza del formato eCTD, GCP e normative globali sulle sperimentazioni cliniche.

Mansioni

• Definire e implementare strategie regolatorie globali.
• Gestire la preparazione e la presentazione di documenti regolatori.
• Collaborare con team cross-funzionali per garantire la conformità normativa.

Conoscenze

Leadership

Project Management

Strategic Thinking

Regulatory Knowledge

Formazione

PhD, PharmD, MD, or MSc in Life Sciences

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 SummaryWe 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 ResponsibilitiesDefine 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.QualificationsAdvanced 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 AttributesExperience 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 offerA contract and salary proportional to the experience (seniority) of the successful candidate.Job locationMilano/Siena (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.

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