Associate Director, Regulatory Strategy

<p>The Associate Director of Regulatory Affairs Strategy will serve as an EU Regional Lead for our mid/late-stage CNS programs and may have the opportunity to be the Regulatory Program Lead for early programs in Alnylam pipeline.

 The will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead the EU regulatory strategy and facilitate submission of data packages to the EMA.

 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 will represent RA on multidisciplinary product development subteams and Global Regulatory Team.

Responsabilidades

include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory

Requisitos

, and interpreting regulatory intelligence for the internal teams.

Summary of Key Responsibilities

• Serve as EU Regional Lead for assigned program (s); additional responsibilities may include serving as 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 EU HA interactions

  Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Paediatric Plans, Orphan Designation and Expedited Pathway Applications (e.

  PRIME), and any amendments.

  </li> <li>Develop detailed regulatory strategy and project plans and support regulatory activities relating to specific port.