Associate Director, Regulatory Strategy

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Massachusetts
Posting date: 09 Apr 2019
RA.KW.22443_1554826933

ProClinical, in support of our client, are seeking an individual to fill the role of Associate Director of Regulatory Strategy, based in Massachusetts. This individual will be responsible for representing Regulatory Affairs, developing regulatory strategies and managing high-quality submissions to regulatory agencies.

Responsibilities

  • Formulate regulatory strategies that provide a streamlined development programs while accurately interpreting and reflecting regulatory and corporate guidelines.
  • Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects.
  • Lead the planning and conduct of meetings with regulatory agencies as appropriate. May represent at regulatory agency meetings as appropriate.
  • Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.

Skills And Qualifications

  • BA, BS or higher in the sciences, or health related field, with 7+ years of regulatory experience.
  • Demonstrated knowledge of drug development process is required.
  • Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
  • Must have prior experience working with FDA or EMA.
  • Experience contributing to successful regulatory filing is required.

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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