Associate Director, Regulatory Affairs

This role is considered Hybrid.

The Regulatory Affairs Associate Director for UK and Ireland has responsibility for the UK regulatory strategy within a development team. Serve as team lead or co-lead of marketing application submissions that are at the regulatory filing stage and life cycle maintenance of registered drugs; helping to develop strategy and content for local dossiers. 

Summary of Key Responsibilities: 

• Participates in the development and implementation of regulatory strategy for the UK for products in development and marketed products, as applicable 

• Manage the process for the successful preparation, submission and timely approval of different applications (CTAs, initial marketing applications, supplements, labeling changes, etc.) and general product life cycle maintenance 

•  Ensure compliance with regulatory requirements and regulatory files 

• Manage interactions with MHRA/HPRA and attend meetings with HA when required 

• Provide strategic regulatory leadership to the Country General Manager to support successful product launches 

• Work closely with supply chain and quality assurance, including UK Qualified person, to identify UK/IE-specific regulatory requirements and potential risks, as well as provide support as needed for obtaining GMP / GDP licenses, as relevant, 

• Work closely with RA strategist to support/follow-up any submission to EMA (variation, commitment…with impact on Ireland) 

• Lead the regulatory review of commercial / medical materials working in partnership with internal groups and external Regulatory partners, if necessary 

• Lead the regulatory review of artworks in partnership with Supply Chain and RA labelling 

• Lead the regulatory review of educational materials if applicable, as the submission and negotiations with MHRA/HPRA 

• Lead negotiations with MHRA/HPRA, as applicable 

• Manage relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met, as applicable 

• Contribute to the preparation of new regulatory guidance and communicate the impact of new regulatory requirements across the organization 

• Maintain dashboard of country-specific activities, including label management and other regulatory activities 

• Provide input into the implementation of a Regulatory Information Management system (RIM), to ensure effective tracking of country-level regulatory activities including label changes, as UK database like emc or IE database as medicnes.ie… 

• Train new member teams, to ensure successful onboarding, as applicable 

Requirements 

• Sound knowledge / experience of working with regulatory authorities, with knowledge of submissions within this area for innovative products in late-stage development and post-approval 

• Sound knowledge / experience of UK Regulatory Affairs and associated requirements, including Brexit

• University Degree in Science or related discipline 

• Experience in interfacing with Regulatory Authorities in Europe and/or MHRA/HPRA, and in building relationships with Regulatory Agencies 

• Ideally a combined mix of large companies, best practices and smaller company adaptability and experience 

• Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills 

• Has strong blend of being a team player, but also able to work on own initiative and prepared to take ownership and responsibility for his/her actions 

• Communication skills to interact with all expertise aera (commercial, medical, PV, supply chain, quality, other regulatory functions) 

• Results focused and able to work under pressure and meet deadlines 

• Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally 

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.