Senior Regulatory Affairs Associate

Excellent BioPharmaceutical Company in Palo Alto, CA seeks Senior Regulatory Affairs Associate!

 

Responsibilities: Reporting to the Senior Director of Regulatory Affairs, the Senior Regulatory Affairs Associate will work closely with the Clinical, Preclinical, Manufacturing, Quality Control and Assurance, Chemistry, and Project Management functions. Under the supervision of the Senior Director of Regulatory Affairs, responsibilities include: Coordinate, prepare, and submit regulatory documents to FDA and other health authorities, including investigator brochures, INDs, IND amendments, NDAs and annual reports, Prepare and submit IND safety reports and related documents, Maintain regulatory documents, including the electronic database of submissions.

 

Requirements: Bachelor?s degree in a scientific discipline; Minimum of 5 years of relevant regulatory affairs experience. Proven track record in regulatory affairs in the pharmaceutical industry, Good working knowledge of small molecule drug development and domestic/ international regulatory issues, Familiarity with electronic document management systems is highly desirable, Team player that has the experience to quickly gain confidence within a fast moving environment, Able to work collaboratively across company boundaries, Diplomatic, self-assured, and flexible in professional and personal approaches, Goal driven and results oriented, Excellent oral and written communication skills; discreet and careful communicator, Ability to present articulately and effectively, High degree of accuracy and attention to detail.