Associate Director, Regulatory Affairs

Overview 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 the US FDA and 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.

The role is expected to serve as a USRegional Lead for for early programs in Alnylam pipeline.  The role will guide regulatory strategy for the assigned programs and represent RA on multidisciplinary product development subteams and program Leadership Teams on those programs. 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 interpreting regulatory intelligence for the internal teams.

This is a hybrid role with onsite presence 2 days a week in either Cambridge, MA or Philadelphia, PASummary of

Key Responsibilities Serve as 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, Investigational New Drug (IND) applications, new Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Pediatric Plans, Orphan Designation and Expedited Pathway Applications (Breakthrough, Fast Track), 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.

Participate as an active team member and 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 ntain 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.

Provide US specific regulatory intelligence to internal stakeholders as appropriate.

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 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., INDs, CTAs, 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…