Vice President, BioPharmaceutical R&D

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Cherry Hill, New Jersey
Posting date: 30 May 2019
RA.NA.23572_1559248009

Seeking a Senior DRA Project Leader for one of Europe's leading biopharmaceutical companies. Successful candidate will provide US regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of projects to Global DRA Project Leader, Clinical Team, Technical Operations and Life Cycle Team.

Responsibilities

  • Liaise with US agencies as primary regulatory contact for projects including planning, coordination, preparation and execution of meetings and teleconferences.
  • Ensure appropriate communication of correspondence between teams and management.
  • Lead creation and maintenance of competitive US labeling in compliance with CCDS and FDA regulations. Lead CCDS creation.
  • Responsible for and contribute to ensuring creation, critical review, finalization of US-specific regulatory documents.
  • Remain current on Regulatory Intelligence, guidance documents and competitive information.
  • Contribute the US regulatory perspective on due diligence activities in support of potential new business opportunities.
  • Collaborate closely with EU-based project partner for regulatory considerations, strategy and key regulatory documents.

Skills and Qualifications

  • Bachelor's Degree in life sciences; higher degree preferred.
  • 8+ years of regulatory experience.
  • Expert knowledge of regulatory legislation and guidelines and other major regulatory systems.
  • In-depth knowledge and experience with FDA regulatory aspects of prescription drug development.
  • Experience with various types of US submissions.
  • Good understanding of the regulatory aspects at various stages of development, from entry-into-man to post-approval activities.
  • Experience working and communicating with the FDA, including coordinating and managing meetings for scientific advice.
  • Familiarity with clinical trial methodology and statistics.

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 Nicole Aganon at (+1) 347-293-1161 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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