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US Liaison / Global Regulatory Team Leader for Mature Products
Ref No.: 17-01582
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date: 11/14/2017
US LIAISON / GLOBAL REGULATORY TEAM LEADER FOR MATURE PRODUCTS
LAWRENCEVILLE, NJ

Project Description:
  • Provide US leadership for Mature Products in various Therapeutic Areas.
  • Ensure maintenance of Mature Products portfolio.
  • Provide strategic regulatory input and prepare content for regulatory strategic documentation, e.g. response to FDA information requests.
  • In partnership with labeling lead facilitate identification of and internal agreement on US labeling and supportive strategy for labeling issues.
  • Lead coordination and preparation for FDA interactions (written, teleconference, F2F meeting).
  • Build a strong and trusted relationship with the FDA project manager.
  • Act as a key contributor for the preparation of responses to queries from FDA and review content.
  • Drive the US FDA submission of all asset related documents such as IND/NDA annual reports.
  • Work with vendor to ensure that regulatory submissions are done in a timely manner.

Required Skills:
  • Solid scientific background, Ph.D., M.D., PharmD, MS or equivalent professional experience.
  • 3-5 years of experience in the pharmaceutical industry. Understanding of scientific content and complexities.
  • Solid knowledge of US regulations, laws, and guidelines. US Regulatory experience a required.
  • Good interpersonal skills; willingness to leverage strengths of the team, coordinate with outsourcing partner and peers within Mature Products Strategy and in a cross functional environment.
  • Ability to communicate issues and risks clearly in written and verbal format to teams and management.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01582
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE