Vice President, Regulatory Affairs 9/7/2016

Confidential Company Hayward, CA

Company
Confidential Company
Job Classification
Full Time
Company Ref #
28536294
AJE Ref #
576112402
Location
Hayward, CA
Job Type
Regular

JOB DESCRIPTION

APPLY
VICE PRESIDENT, REGULATORY AFFAIRS

California

Reporting to the CEO, this highly visible leadership position requires a solid hands-on mentor to lead the regulatory team and global regulatory strategy.

Relocation available.

RESPONSIBILITIES:

* 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

QUALIFICATIONS:

* 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