Associate Director, Regulatory Strategy

原始資料於 2026-11-04T15:07:12.038688+00:00 查閱；內容可能已更新，請查看原始職位。

Qualifications
Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience working in the biotech or pharmaceutical industry. Higher degree would be a plus.
Excellent written and verbal communication skills, including negotiation and influencing skills.
Solid understanding of regulations and experience in interpretation of guidelines.
Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.
Experience with regulatory filings, including electronic submissions, e.g., CTAs, post-marketing variations, safety reporting, paediatric plans, PRIME etc.
MAA filing and Type II variation experience is preferred.
Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
Clear alignment with Alnylam Core Values including:
Commitment to People,
Fiercely Innovative,
Purposeful Urgency,
Open Culture, and
Passion for Excellence.
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.
Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
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