[jsfg_cinti] Job Posting: Director Regulatory Affairs
- From: JSFG@xxxxxxxx
- To: JSFG@xxxxxxxx, jsfg_cinti@xxxxxxxxxxxxx
- Date: Wed, 11 Jun 2008 11:37:09 -0400 (EDT)
The following job opportunity has been posted to the JSFG E-mail Mailing List.
Date: 6/11/08
JobTitle: Director Regulatory Affairs
JobClass: Professional
JobDescript: Director, Regulatory Affairs - Columbus, OH
The Director, Regulatory Affairs will ensure the Company's compliance with
associated regulatory obligations. Reports directly to the Vice President,
Regulatory Affairs & Quality Assurance. Prepare regulatory submissions and
other regulatory documentation to the FDA and other regulatory agencies.
Perform duties as deputy liaison between the Company and regulatory agencies
concerning regulatory compliance issues.
Location: Columbus, Ohio
Requirements_Qualif: B.S. in Biology, Biochemistry, or Health related field
requires; M.S. or Ph. D. preferred; five to ten years of significant regulatory
affairs with a pharmaceutical and/or Biologics Company required; experience in
pharmaceutical product development and/or experience in clinical research a
plus; demonstrates knowledge of Good Clinical Practice (GCP), Good
Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements
as well as federal and state regulatory responsibilities associated with
clinical studies; technical writing and statistical analysis ability; excellent
communication and organization skills. Base, bonus, benefits and full
relocation package provided.
WorkType: Salaried
Travel: No
PositionState: New
SalaryRange: $$85-90+
HowApply_Email: Yes
Company: Guthoff & Associates
Person_Requesting_Profiles: Joanne Davis
Contact_StreetAddress: 659 A Park Meadow Rd
Contact_City: Westerville
Contact_State: oh
Contact_ZipCode: 43081
Contact_WorkPhone: 614-794-9950
Contact_FAX: 614-794-9951
email: pguthoff@xxxxxx
Industry: Executive Search
Comments: All searches are fee paid by our clients. We work both contigency and
retained.
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