Director of Regulatory Affairs
hace 21 horas
Hayes
The role: • 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 Regulatory Affairs will be responsible to provide strategic guidance for regulatory activities supporting expanded access programs conducted on behalf of biotech and pharmaceutical companies., • In addition, this 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 to it, 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 and implementation and ongoing delivery of programs once awarded., • As such, the role requires a broad knowledge of international regulations to support both internal and external stakeholders with access to unlicensed and unregistered medicines., • The Director of Regulatory Affairs must be able to work in a demanding environment where timelines and protocols must be met. Focused on managing and documenting information, 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., • Responsible for supporting regulatory Due Diligence of potential acquisitions/partnered product opportunities etc., • 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., • 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., • 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., • 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 organisation regarding unlicensed medicines frameworks and launch processes., • Team & Vendor Management, • Lead and mentor regulatory team members, fostering growth and high performance. Essential • 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, • 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., • 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. Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. With a workforce of more than 3,000 spread across Ireland, United Kingdom, Mainland Europe, MENA and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines and treatments around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Uniphar Supply Chain & Retail, Uniphar Medtech and Uniphar Pharma Uniphar Pharma Pharma is a global division operating across US, Europe, APAC and MENA, bringing a range of pharma services to manufacturers across the product life cycle. We leverage this platform to provide unlicensed medicines, or medicines that are otherwise difficult to source. In addition, we commercialise launch and established brands to HCPs on behalf of pharmaceutical clients across the globe. The core to this division is providing equitable access to medicines globally. Culture at Uniphar From our leadership team and across all of our divisions, Uniphar lives and breathes four key culture pillars: 1.We have a People First approach, we do the right thing and take a stand for our people. 2.We foster a strong Entrepreneurial Spirit where Adaptability, Commitment & Resilience is embodied in our way of working. 3.We have a Common Purpose that connects our diversified businesses and people. 4. Finally, Trust is at the heart of how we operate. How we’d like to work together As we are a global team, there is flexibility to be based in one of Uniphar’s offices or work from home. There may be a need for face to face meetings in other locations, as needed.There may also some flexibility required in order to interact with colleagues or clients in their time zones (i.e. it’s not a ‘9 to 5’ type of job). In return, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it through our Hybrid Working philosophy. Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses.
