Associate Director, Regulatory Affairs

This role is considered Hybrid.

The Associate Director of Regulatory Affairs Strategy, will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to US other international health agencies (HA).  The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration for their assigned programs. The role may serve as regulatory representative on multidisciplinary product development subteams and core teams. The role is expected to serve as US Regional Lead for early programs in Alnylam pipeline.  Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and distributing regulatory intelligence to the internal teams.

Key Responsibilities

• Serve as a US Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.

• Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead US HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway Applications, and any amendments.

• Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.

• Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.

• Provide strategic regulatory advice to project teams.

• Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.

• Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.

• Maintain regulatory files in a format consistent with internal requirements.

• Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.

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.

• Excellent written and verbal communication skills, including negotiation skills.

• Solid understanding of regulations and experience in interpretation of guidelines.

• Ability to think strategically and to proactively identify issues in various aspects of the drug development process.

• Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.

• 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.

• RAC certification and/or advanced degree are preferred 

• Clear alignment with Alnylam Core Values

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.