Associate Director/ Director, Regulatory Affairs - Sunnyvale CA, CA | Biospace
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Associate Director/ Director, Regulatory Affairs

GQR Global Markets

Location:
Sunnyvale CA, CA
Posted Date:
12/21/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Under the Sr Director, Regulatory Affairs, the Associate Director will lead cross-functional teams by providing regulatory strategy and support to global development.

- Support major filing activities and Health Authority interaction and meetings.
- Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, study plans, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions.

Email Nicole.Leinders@gqrgm.com or call (917)460-0157 for more details.

Requirements

REQUIREMENTS:
- Must understand clinical and pre-clinical study results in order to ensure alignment with regulatory positions and strategy .
- 6 years of regulatory experience in industry with experience leading NDA/sNDA and/or BLA/sBLA filings.

Must be US citizen or green card holder, relocation unavailable.

Compensation: Competitive
Start Date: ASAP
Length: Permanent
Location: South San Francisco

This is an awesome opportunity for an Associate Director Regulatory Affairs to help advance cutting edge science and bring effective therapies to those suffering from various autoimmune diseases. Company has a robust pipeline and backing by a global pharmaceutical company, so now is the time to join their team!

Email Nicole.Leinders@gqrgm.com or call (917)460-0157 for more details.