Regulatory Affairs Team Lead

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Location
Any US City
Salary
$1 - $1
Job Type
Direct Hire
Date
May 25, 2017
Job ID
2486598
Regulatory Affairs Team Lead
New Jersey
Massachusetts
 
Our client, a global pharma company has a new opportunity for a Team Lead level  professional with Regulatory Affairs/Oncology expertise to drive US and Global Oncology projects. This is a full-time Team leader level role driving regulatory strategy of oncology drugs.
Independently manages all regulatory business strategies for oncology products throughout lifecycle.  Responsible for the regulatory strategy of submissions for all products as well as managing interactions with regulatory authorities on regulatory issues.
 
Responsibilities:
  • Create, implement and drive regulatory strategy to achieve corporate objectives
  • Cross functional project management experience in RA/CMC, strategy, operations, advertising/promotions/labeling
  • Act as liaison with FDA for oncology projects
  • Must be a hands-on driver of regulatory strategy from submission deadlines and execution to post-marketing
Qualifications:
  •  7+ years in Regulatory Affairs, 5+ years in a leadership role
  • Ph.D, PharmD, or MD highly preferred, not required
  • Must have been part of a team that had a successful NDA or BLA
  • Extensive experience with late stage development and commercial products
    The successful candidate will be highly knowledgeable in US and global CMC Regulatory Affairs and have a track record of success in the drug approval process, strong interpersonal & leadership skills, and strong project management skills. 
  • Previous FDA negation and interaction


Additional notes: Global Regulatory experience in Oncology is required. Relocation is offered.  Compensation and benefits for this opportunity very strong.