The Director of Regulatory Affairs is responsible for assigned regulatory strategy and operations related to unlicensed medicines (ULMs), early access programs, and commercial product launches across Europe. This role ensures regulatory compliance while enabling timely patient access to critical therapies. The Director will help define regulatory frameworks, engage with health authorities, manage end‑to‑end launch readiness, and collaborate cross‑functionally to support business growth and operational excellence.
* They will work in partnership with the Head of Regulatory Affairs, Business Unit Directors and the project teams to ensure that they are able to deliver best‑in‑class service and business support across the Division.
* The Director will provide strategic guidance for regulatory activities supporting expanded access programs conducted on behalf of biotech and pharmaceutical companies.
* Additionally, the role will provide strategic advice and leadership for all regulatory activities supporting the approval and lifecycle management of biotechnology clients’ assets, ensuring successful regulatory submissions and compliance across global markets (e.g., EMA, MHRA, Swiss Medic).
* The role has a significant client‑facing element, acting as a Subject Matter Expert (SME) to support the business development team with prospecting for new business opportunities and in support of the design, implementation, and ongoing delivery of programs once awarded.
* It requires a broad knowledge of international regulations to support both internal and external stakeholders with access to unlicensed and unregistered medicines.
* The Director must be able to work in a demanding environment where timelines and protocols must be met, focus on managing and documenting information, and be proficient at working with databases and other information management tools.
* Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent organizational, analytical, project management, and communication skills.
Specific Job Responsibilities
Regulatory Strategy & Leadership
* Work alongside the Head of Regulatory Affairs to shape the regulatory function and ensure best‑in‑class services.
* Develop and execute European regulatory strategies for unlicensed medicines, Named Patient Programmes (NPP), Early Access Programmes (EAP), and Compassionate Use.
* Support regulatory due diligence of potential acquisitions/partnered product opportunities.
* Lead regulatory planning and readiness for new commercial launches, ensuring alignment with development, medical, commercial, quality, and supply chain teams.
* Serve as the senior regulatory expert for ULMs and launches, advising executive leadership on risks, opportunities, and regulatory pathways.
* Interpret and apply EU and national regulatory frameworks to ensure full compliance across markets.
Health Authority Engagement
* Manage proactive interactions with EU/EEA health authorities to discuss ULMs, early access plans, and launch‑related submissions.
* Prepare, review, and lead regulatory meetings, scientific advice, and written communications with regulators.
* Build positive working relationships with competent authorities, including MHRA, EMA, and national agencies.
Regulatory Operations & Compliance
* Oversee preparation, submission, and lifecycle management of regulatory filings related to ULM supply, importation, and distribution.
* Ensure compliance with all relevant regulations, including advertising & promotion, pharmacovigilance requirements, GDP/GMP interfaces, and market‑specific obligations.
* Establish and maintain SOPs, governance processes, and documentation required to support audit‑ready operations. Support the maintenance of the Regulatory Intelligence repository for the supply of unlicensed medicines.
Launch Excellence
* Lead regulatory input into cross‑functional launch teams for new product introductions.
* Manage preparation of core regulatory documents, including SmPCs, PILs, labeling, packaging, variations, and launch notifications.
* Provide guidance on regulatory aspects of pricing & reimbursement, HTA submissions (where relevant), and post‑launch lifecycle management.
Cross‑Functional Collaboration
* Work closely with Medical Affairs, Quality, Supply Chain, Commercial, Legal, and Market Access teams to enable compliant and efficient product availability.
* Act as internal consultant for regulatory implications of business decisions, supply challenges, and commercial planning.
* Support training and capability building across the organization regarding unlicensed medicines frameworks and launch processes.
Team & Vendor Management
* Lead and mentor regulatory team members, fostering growth and high performance.
* Manage external regulatory consultants, distributors, and service providers to deliver high‑quality outputs.
Qualifications & Experience
* Advanced degree in life sciences (PharmD, MSc, PhD, MD) or equivalent.
* 8+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
* Proven track record of leading regulatory activities for commercial product launches in Europe.
* Experience engaging with EU/National health authorities.
* Relevant experience in a client‑facing role.
* Proven ability to provide coaching, advice and mentoring in areas of Regulatory Affairs.
* Excellent understanding of GMP/GDP interfaces, QA interactions, and supply chain requirements.
Preferred
* Previous experience in EU regulatory frameworks for unlicensed medicines (e.g., Named Patient, Early Access, Compassionate Use).
* Experience in specialist areas such as orphan medicines, oncology, rare diseases, or biologics.
* Familiarity with HTA and P&R processes.
* Prior leadership of distributed or matrixed teams.
* Strong business acumen and ability to partner effectively with commercial stakeholders.
Skills & Competencies
* Strategic thinking: Able to shape regulatory strategy in complex or ambiguous environments.
* Leadership: Inspires teams, builds trust, and drives execution.
* Regulatory expertise: Deep understanding of European regulations and unlicensed medicine pathways.
* Communication: Clear and credible communicator with internal stakeholders and regulators.
* Problem‑solving: Proactive, solutions‑oriented mindset with strong judgment.
* Cross‑functional influence: Effective collaborator across medical, commercial, quality, and supply chain teams.
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