Sr. Associate, Regulatory Affairs

This role is considered Hybrid.

Overview

The Senior Associate of Regulatory Affairs will report to Director of Global Regulatory Affairs, Strategy, located in Maidenhead, UK. The role will provide cross-program support to prepare and facilitate submission of regulatory packages to a variety of international health authorities (HA) to support product development, clinical trials, product registration and post-approval life-cycle management.

This is a hybrid role office based 2x days week in Maidenhead, UK.

Key Responsibilities

• Work with Regulatory Regional Lead(s) within cross-functional teams to support and contribute to regulatory strategy through the completion and timely submission of regulatory documents according to regulatory requirements. Regulatory documents may include relevant forms, meeting requests, new Clinical Trial Applications (CTAs, INDs) and any amendments, periodic reports (e.g. DSUR, PBRER), and variations for post-authorization changes to Marketing Authorizations.
• Coordinate responses to regulatory authorities’ questions, e.g. in response to queries on CTAs or variations, with strict adherence to agency deadlines.
• Coordinate all aspects of paper and electronic regulatory submissions and maintenance of regulatory files in a format consistent with internal requirements in accordance with SOPs.
• Develop, maintain and track detailed regulatory project plans and timelines, and support regulatory activities relating to assigned products/projects.
• Additional responsibilities include writing documents and oversight of preparation of technical regulatory documents, including facilitation of coordinated review of regulatory documentation and implementation of changes to documentation as relevant.
• Serve as member of Global Regulatory Team(s), may serve as Regulatory representative in multidisciplinary product sub-teams for assigned programs and participate as an active team member.
• Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.
• Proactively keep updated on relevant regulatory requirements, and where necessary distributing regulatory intelligence to the internal teams.

Qualifications

• Bachelor's degree in scientific discipline ideally with 1 to 2 years’ experience in a Regulatory Affairs role in biotech or pharmaceutical industry, or PhD in scientific discipline without industry experience
• Understanding of regulations and experience in interpretation of guidelines.
• Excellent written and verbal communication skills, including negotiation and influencing skills.
• Excellent organizational and project management skills; demonstrated ability to prioritize and deliver multiple projects.
• Strong critical thinking skills
• Ability to work in a matrixed-team environment, possessing good interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
• Ability to think strategically and develop solutions through generation of different options; proactively identify issues and mitigation strategies associated with assigned work.

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.