Company Name:
Approximate Salary:
Not Specified
Location:
La Jolla, California
Country:
United States
Industry:
Operations
Position type:
Full Time
Experience level:
6-9 Years
Education level:
Bachelor's Degree
Street:
3344 N. Torrey Pines Crt., Ste. 200
City:
La Jolla
State:
California
Fax:
858-875-8650
ID
164727
Phone:
858-875-8690

Director, Regulatory Operations

The Director, Regulatory Operations will be responsible for leading the day-to-day Regulatory Operations function and growing/overseeing the Regulatory Operations Team. The incumbent will be accountable for the overall planning and management of Regulatory Operations resources (internal and external) to effectively support timely and high-quality submissions to Global Regulatory Authorities (i.e., FDA, EMA, etc.). He/She will be responsible for creating/implementing operational processes and standards necessary to assure compliance with regulatory requirements and submission timelines.  He/she will remain current with evolving regulations, new Guidance and innovative practices related to electronic publishing and regulatory operations and will ensure implementation of new systems and procedures, as appropriate.