Sr. Manager, Regulatory Affairs, CMC

 This role is considered Hybrid.

The Sr Manager, Regulatory Affairs CMC is responsible for supporting and executing department-wide global regulatory compliance and process improvement strategies, with input from key Regulatory, Quality and CMC stakeholders. These strategies ensure Alnylam’s program(s) meet global health authority requirements and remain compliant throughout the lifecycle of the product. This role will support core capabilities and strategic innovation activities of the RA CMC team, allowing for global clinical development, registration, and product life cycle management in a streamlined, efficient, and compliant manner.

This position reports to the Director of Regulatory Affairs CMC, or equivalent.

This role is hybrid based 2 days week in the office in Maidenhead, UK or Amsterdam, The Netherlands.

Summary of Key Responsibilities:

· Ensures that regulatory submissions and CMC projects align with RA CMC best practices and defined regulatory strategy/program objectives. Proactively identifies compliance gaps or process improvement needs and works with the RA CMC team to develop mitigation proposals.

· Contributes to the implementation of process improvement initiatives supporting the RA CMC function

· Support generation and reporting of metrics for the RA CMC team (i.e change control, submission metrics)

· Contribute to development of best practices and standardized processes

· Maintain project dashboard(s)

· Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments.

· Actively participates in the development of regulatory CMC infrastructure and capability building.

Requirements

· BS in science related field required, advanced degree (eg MS, PhD) preferred.

· Minimum 4-6 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 2 years of RA or CMC experience.

· Experience working on GMP inspections, audits, investigations or other quality systems, Experience in formal risk assessment (i.e. FMEA) a plus

· Process improvement experience; Lean/Six Sigma certifications a plus

· Sound understanding of chemistry and biology. Experience in oligonucleotides is a plus.

· Knowledge and understanding of US, EU, Canada, and ICH guidelines as well as understanding of international CMC requirements. Combination products experience a plus

· Strong interpersonal skills and the ability to effectively collaborate with various technical area experts.

· Excellent verbal and written and communication skills.

· Demonstrated strong organizational skills including ability to review and execute complex project plans.

· Highly computer literate (eg, Word, Excel, PowerPoint).

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.