Vice President, Regulatory Affairs
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POST DATE 9/7/2016
END DATE 12/19/2016
JOB DESCRIPTIONVICE PRESIDENT, REGULATORY AFFAIRS
Reporting to the CEO, this highly visible leadership position requires a solid hands-on mentor to lead the regulatory team and global regulatory strategy.
* Create Regulatory strategy
* Hire, lead, and mentor and Regulatory team
* Lead FDA and global regulatory communications and meetings to ensure compliance and work towards approval
* Lead global regulatory submissions, which include: NDA, IND, MAA, CTA
* Collect data for regulatory agency submissions from CRO's globally.
* Outline strategy and timelines to produce regulatory documents
* MD, Ph.D, or PharmD
* 15+ years' global regulatory experience.
* Deep understanding of NDA and IND submissions and a track record of success
* Experience with global regulatory agencies and requirements.
* Minimum of 15 years' pharmaceutical Regulatory experience
* Oncology experience is required
* Effective communication skills (oral and written)
* Superb leadership and team management skills