What are the responsibilities and job description for the Manager, Regulatory Affairs, CMC position at Alnylam Pharmaceuticals?
This role is considered Hybrid.
Responsibilities
The Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for commercial programs. The Manager is a key member of multidisciplinary teams responsible for the preparation of high-quality regulatory submissions focusing on chemistry, manufacturing, and controls (CMC) for programs to support life cycle management and global expansion. This position reports to the Director of Regulatory Affairs CMC, or equivalent.
Summary Of Key Responsibilities
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.
Responsibilities
The Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for commercial programs. The Manager is a key member of multidisciplinary teams responsible for the preparation of high-quality regulatory submissions focusing on chemistry, manufacturing, and controls (CMC) for programs to support life cycle management and global expansion. This position reports to the Director of Regulatory Affairs CMC, or equivalent.
Summary Of Key Responsibilities
- Contributes to the implementation of the global regulatory CMC strategy for commercial programs.
- Ensures that regulatory submissions and CMC projects align with the defined regulatory strategy. Proactively identifies gaps and works with CMC teams to develop mitigation proposals.
- 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.
- BS in science related field required, advanced degree (eg MS, PhD) preferred.
- Minimum 2-4 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 2 years of regulatory affairs CMC experience.
- 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.
- 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).
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.
