Director of Regulatory Affairs

Role Overview

As our regulatory team continues to grow, we have an exciting opportunity for an experiencedDirector of Regulatory Affairsto join us. This role will focus on pioneering cell and gene therapy products across Europe. The successful candidate will be part of a global regulatory affairs team, overseeing the preparation, submission, and review of regulatory applications for health authorities across Europe and beyond.

This position provides a unique opportunity to work onAdvanced Therapy Medicinal Products (ATMPs)in key therapeutic areas. The role involves collaborating with cross-functional teams, shaping regulatory strategies, and contributing to the advancement of a cutting-edge therapeutic portfolio.

Key Responsibilities

• Develop and implement regulatory strategies in collaboration with internal teams.
• Assess regulatory risks and provide solutions to mitigate potential challenges.
• Act as the primary contact with regulatory agencies, leading key interactions.
• Plan, coordinate, prepare, and submit major regulatory applications (e.g., PIP, Orphan Designation, Variations).
• Manage the approval process and regulatory maintenance throughout the product lifecycle.
• Lead the development and timely submission of responses to regulatory agency inquiries.
• Organize and execute regulatory agency meetings, including preparing scientific advice packages.
• Provide regulatory leadership for clinical studies, including overseeing documentation and submission planning.
• Author and review key regulatory submission documents in collaboration with internal and external teams.
• Ensure compliance with ATMP regulations while keeping up to date with evolving international requirements.
• Monitor the competitive landscape and provide regulatory insights to project and clinical teams.
• Support cross-functional teams, including research, manufacturing, and clinical operations, ensuring high-quality regulatory submissions.
• Ensure that all regulatory activities align with internal compliance policies and industry regulations.
• Adhere to company health and safety standards.

Required Skills and Experience

Experience (E = Essential, P = Preferred)

• E– At least 8 years of experience in the biotech or pharmaceutical industry, with a minimum of 5 years in regulatory affairs, including post-marketing experience.
• E– Strong knowledge of gene therapy regulations and international guidelines related to ATMPs.
• E– Proven experience leading major regulatory submissions, including MAA, PIP, Orphan Designation, and major variations.
• E– Expertise in regulatory project management, including coordination of multiple submissions.
• E– Strong writing skills for scientific and regulatory documentation.
• E– Experience in leading scientific advice meetings and engagements with regulatory agencies.
• E– Proficiency with regulatory information management tools (e.g., Veeva).
• E– Excellent communication skills and the ability to work collaboratively across teams in different locations.
• E– Strong organizational skills, with the ability to prioritize tasks and meet deadlines.
• P– Experience withClinical Trial Authorisation (CTA)applications in Europe, with USINDexperience considered an asset.
• P– Familiarity with regulatory submissions related to environmental risk assessments/GMO requirements for gene therapy products.
• P– Knowledge of regulatory requirements for medical devices, including IDEs and CE certification.

Qualifications

• E– A Master’s degree or equivalent in pharmacy or life sciences, with a strong pharmaceutical or medical background.