Associate Director, Regulatory Affairs, CMC

This role is considered Hybrid.

Responsibilities:

The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. The Associate Director is a key member of multidisciplinary teams responsible for preparation of high-quality regulatory submissions focusing on chemistry, manufacturing, and controls (CMC) for lifecycle management and global expansions of the commercial programs. This position reports to the Senior Director of Regulatory Affairs CMC, or equivalent.

Summary of Key Responsibilities:

• Assists in the development and execution of a robust global regulatory CMC strategy using balanced, risk-based approaches for the commercial programs. The role directly collaborates with cross-functional CMC and Global Regulatory Teams to achieve strategic company objectives.
• Leads and manages the preparation of high-quality CMC regulatory submissions.
• 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 6-8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 4 years of regulatory affairs CMC experience, including direct experience in developing and executing global regulatory strategy.
• Sound understanding of chemistry and biology. Experience in oligonucleotides is a plus.
• Experience in managing complex submissions and CMC changes (eg process, facility, formulation) in a global setting.
• Knowledge and understanding of US, EU, Canada, and ICH guidelines. Understanding of international CMC requirements is a plus.
• Proven ability to develop creative regulatory solutions for expedited programs, rare diseases, and/or platform technology
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts and internal or external partners.
• Excellent verbal and written communication skills.
• Demonstrated strong organizational skills including ability to derive 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.