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Global Regulatory Strategy Lead
Ref No.: 18-00642
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date / End Date: 05/15/2018 to 11/14/2018
GLOBAL REGULATORY STRATEGY LEAD
LAWRENCEVILLE, NJ

Project Description:
  • Global Regulatory Strategy Lead (GRTL) Marketed Product Development will have leadership responsibility for global regulatory strategy within the Marketed Product portfolio.
  • Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
  • Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
  • Develop target labeling and co-lead the cross functional labeling team.
  • Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
  • Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
  • In collaboration with the GRT, develop global submission plans and HA interaction plans.
  • Provide input into the development of protocol synopses and protocols.
  • Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Required Skills:
  • PhD, MD or MS with 5+ years in the pharmaceutical industry.
  • Experience in successfully leading teams; ability to broadly represent Marketed Product Development functions on project team.
  • Experience as a member of GRTs, project working groups, or comparable experience.
  • Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with communication of regulatory strategy, issues, and risks in written and verbal format to MPD SLT and other governing bodies.
  • Experience utilizing leadership techniques to drive a team through the stages of team development.
  • Experience coordinating communications within teams and across functions.
  • Experience applying project management techniques within teams.
  • Experience in effectively managing meetings.
  • Demonstrated ability to breakdown complex, scientific content into logical components.
  • Demonstrated ability to coordinate global activities.
  • Demonstrated ability to facilitate issue resolution and I conflict management.
  • Demonstrated ability to drive quality decision-making. Demonstrated ability to organize/prioritize tasks.
  • Demonstrated ability to negotiate with and influence others.
  • Understanding of strategic and tactical role of MPD in the drug development process.
  • Understanding of general global regulatory requirements for drugs in development.
  • Understanding of PD&C process and specific MPD responsibilities/deliverables at PD&C Decision Points.

This 6+ month position starts ASAP.

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

ALPHA'S REQUIREMENT #18-00642
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE