Sr. Manager, Regulatory Affairs

<p>The Senior Manager, Regulatory Affairs will work with EU regulatory lead(s) and/or directly with global regulatory lead(s) and within cross-functional teams to facilitate submission of applications to EU and International health agencies (HA) for Alnylam’s RNAi therapeutics.

 The role will work across programs to support the development of Alnylam’s products globally.

 In doing so they are responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration.

The role will contribute to regulatory strategy and may represent the department on multidisciplinary product development subteams.

 Additional.

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 internationally as relevant, and distributing regulatory intelligence to internal teams.

Summary of Key Responsibilities

• Work with EU/Global regulatory lead  to lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory submissions throughout the product's life cycle.  This may include relevant forms, new Clinical Trial Applications (CTAs) responses to questions, substantial modifications, notifications etc, meeting requests, Briefing Documents for HA meetings.  Role may also include supporting preparation of  Paediatric Plans, Orphan Designation, Expedited Pathway Applications (e.g

  PRIME), and Marketing Applications and any amendments.

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

  </li> <li>Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams for assigned pro.