Head Of Regulatory Affairs

Alfasigma; Monza; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Head of Regulatory Affairs to oversee global regulatory compliance and strategy. This pivotal role requires extensive experience with EMA and FDA pathways, and strong leadership abilities to guide regulatory submissions across all product development stages.

Competenze

• Minimum 10 years experience in Regulatory Affairs within pharma/biotech.
• Proven track record with EMA and FDA interactions across development phases.
• Strong knowledge of GCP and ICH guidelines.

Mansioni

• Define and implement global regulatory strategies.
• Lead preparation and submission of regulatory documents.
• Collaborate with cross-functional teams.

Conoscenze

Leadership

Communication

Project Management

Formazione

PhD, PharmD, MD, or MSc in a life sciences discipline

Strumenti

eCTD

Descrizione del lavoro

Philogen S.P.A. would like to hire a highly motivated and qualified 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 - ItalyWe 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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