Manager, Regulatory Affairs - Canada

Key Responsibilities

• Manage the preparation, negotiations, and execution of high-quality submissions (NDS, SNDS, CTA).
• Participate/lead conversations and regulatory contacts and negotiations with Health Canada.
• Prepare and review the responses to Health Canada’s questions in collaboration with global teams, as applicable.
• Manage and conduct meetings with Health Canada, including preparation of pre-submission packages and presentations, as applicable.
• Provided regulatory evaluation and recommendation for different projects.
• Review promotional and non-promotional materials and ensure compliance with external and internal regulations.
• Ensure regulatory compliance of products.
• Ensure RA activities to secure launches according to commercial deadlines.
• Contribute to regulatory guidance and regulatory intelligence environment scan and communicate the impact across the organization.
• Maintain dashboard of country-specific activities, including label management and other regulatory activities.
• Provide input into the Regulatory Information Management system (RIM), to ensure effective tracking of country-level regulatory activities including label changes.

Qualifications

• Knowledge of Health Canada regulations.
• Knowledge of advertising and promotional review requirements for prescription drugs in Canada
• Knowledge / experience of working with Health Canada.
• University Degree in Science or related discipline.
• 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 areas (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.
• This role is remote.
• Veeva knowledge is preferred.
• Bilingual in English & French is preferred.

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.