Program Director

il y a 4 jours


Paris, Ile-de-France Meet Temps plein

The Program Director of Regulatory Affairs will spearhead the development, planning, and execution of regulatory programs for our diverse portfolio. This role will involve close collaboration with cross-functional teams, including clinical, quality, and product development, as well as external regulatory agencies. The successful candidate will play a pivotal role in aligning our regulatory strategy with our overall business objectives, supporting product lifecycle management, and facilitating market access.


Key Responsibilities

  • Strategic Leadership: Develop and execute regulatory strategies to ensure compliance across all products and markets, anticipating and addressing regulatory challenges.
  • Programme Management: Lead and manage a portfolio of regulatory projects from inception to completion, ensuring timely submission of documentation and securing approvals.
  • Stakeholder Collaboration: Work closely with internal teams and external regulatory bodies to communicate regulatory requirements and align on submission strategies.
  • Policy & Compliance: Keep updated with global regulatory requirements and trends, interpreting regulatory guidance to implement best practices and ensure compliant processes.
  • Risk Management: Identify potential regulatory risks and develop mitigation strategies, advising senior leadership on regulatory impact.
  • Team Development: Mentor and develop a high-performing team, providing guidance and support for individual growth and team cohesion.


Qualifications and Experience

  • Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred (MSc, PhD, or equivalent).
  • Experience: 15+ years in Regulatory Affairs within [industry, e.g., pharma, biotech, medtech], with a proven track record of regulatory submissions and approvals. At least 5 years in a leadership role, preferably with Global exposure.
  • Regulatory Knowledge: Strong understanding of FDA, EMA, and other relevant regulatory bodies; deep familiarity with industry standards and guidance documents.
  • Project Management: Exceptional organizational skills with experience in managing multiple large-scale projects simultaneously.
  • Interpersonal Skills: Excellent communication and negotiation skills, with an ability to work effectively across levels and departments.
  • Analytical Mindset: Strong problem-solving skills, capable of making strategic decisions and influencing organizational direction.
  • Professional Certification: RAC or similar Regulatory Affairs certification is highly desirable.


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