Senior RA Manager - Strategy

Highly Competitive Salary
  1. Permanent
  2. Project Manager
  3. United States
Boston, Massachusetts
Posting date: 09 Apr 2019
RA.NW,17728_1554814822

ProClinical, in support of our client, are seeking an individual to fill the role of Senior RA Manager, Strategy. The successful candidate will participate in the development and implementation of regulatory strategy for specific programs, and may take the lead on the design and execution of certain sections of regulatory submissions.

Responsibilities

  • Manage and implement EU regulatory strategies in support of assigned projects and sub-teams for centrally approved orphan medicinal products and products currently in clinical development.
  • Working closing with the regulatory sub-team and cross-functional stakeholders.
  • For products in development, primary responsibilities will involve planning, preparation and submission support for EU clinical trial applications, scientific advice procedures, orphan designation requests, and Pediatric Investigation Plans (PIPs)
  • Plan, prepare and submit MAA variations, Renewal documents, post-marketing commitment submissions, PSURs and other ad hoc activities in support of maintaining the marketing authorizations.

Skills And Qualifications

  • BS and 5+ years of regulatory work experience.
  • Experience preparing, submitting, and working closely with EMA.
  • Capable of strategic thinking and proposing innovative solutions to regulatory problems.
  • Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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