Senior Director Regulatory Affairs

Senior Director Regulatory Affairs

Philogen S.p.A. is a biotechnology company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies. As we expand our clinical development activities, we are strengthening our Regulatory Affairs organization.

We are currently seeking a highly motivated, experienced Senior Director, Regulatory Affairs to support the development and execution of regulatory strategies across our pipeline. The successful candidate will report to the Head of Regulatory Affairs and will play a pivotal role in guiding regulatory planning and delivering key submissions to support the company’s products.

The role requires a strong regulatory background, the ability to manage complex submissions, and close collaboration with cross-functional teams across the organization.

Key Responsibilities

• Develop and contribute to regulatory strategies supporting clinical development programs and product lifecycle management.
• Lead and manage activities related to the preparation, submission, and approval of regulatory dossiers with global regulatory authorities (including EMA and FDA ).
• Coordinate and prepare regulatory submissions such as INDs, CTAs, MAAs, variations, and scientific advice procedures .
• Ensure regulatory documentation is accurate, complete, and compliant with applicable regulatory requirements and company objectives.
• Act as a key regulatory contact for project teams, providing strategic regulatory input during product development.
• Interact with regulatory authorities and support regulatory meetings and communications.
• Review and contribute to regulatory sections of clinical and development documentation.
• Ensure regulatory compliance throughout the development lifecycle, including maintenance activities for approved products.
• Support the preparation and management of regulatory documentation, including eCTD submissions .
• Maintain up-to-date knowledge of global regulatory requirements, guidelines, and industry best practices.
• Contribute to internal regulatory processes, documentation, and SOP development.
• Collaborate closely with Clinical, Quality, CMC, and other internal departments to ensure alignment of regulatory strategies.

Requirements

• University degree in Life Sciences, Pharmacy, or a related scientific discipline.
• At least 10 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Strong experience with global regulatory submissions and regulatory lifecycle management .
• Solid understanding of ICH guidelines and global regulatory frameworks , particularly EMA and FDA .
• Experience with eCTD submissions and regulatory documentation management.
• Ability to work cross-functionally and manage multiple projects in a dynamic environment.
• Strong written and verbal communication skills.
• Fluent in English (written and spoken).

We offer

A contract and salary proportional to the experience of the successful candidate.

Job location:

Milano or Siena - Italy

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.