Director, Regulatory Strategy, Pipeline Products

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Cambridge, Massachusetts
Posting date: 13 May 2019
RA.KW.23324_1557759257

ProClinical, in support of our client, are seeking an individual to fill the role of Director of Regulatory Strategy, Pipeline Products, based in Cambridge MA. The successful candidate will work with the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science.

Responsibilities

  • Design creative regulatory strategy for the global development for several products in the severe genetic disease portfolio.
  • Manage preparation and submission of high-quality dossiers.
  • Lead transparent and proactive interactions with regulatory agencies globally.
  • Collaborate with regulatory-CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
  • Drive adherence to regulatory guidelines for development of gene therapy products.
  • Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends.

Skills and Qualifications

  • Advanced degree in a related pharmaceutical field. 8+ years of regulatory experience in a biotech/pharma company and 5+ years of regulatory experience in advertising and promotional material review.
  • Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent written, verbal, and interpersonal communication skills.

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 Kyle Weber at (+1) 646-367-2618 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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