Regulatory Affairs Manager Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2397989
Location: South San Francisco, California	Date Posted: 7/26/2008
Wage:	Category: Medical/Health
Job Code: 6833527

Job Description:
RESPONSIBILITIES include the following. Other duties may be assigned. Lead regulatory operations aspects by ensuring timely and quality submission of marketing materials to the Food and Drug Administration\'s Division of Drug Marketing, Advertising and Communications for consultation (Subpart H review) and Responsible for preparation of moderately complex regulatory submission including subpart H prospective review and at the time of first use as well as coordination of promotional materials and implementation of ARC database Oversee regulatory process to ensure that content, quality, accuracy and format of submission ready components and final submissions comply with applicable laws, regulations, and corporate standards. Ensure that changes from previous ARC feedback and comments and approved product labeling are reflected in the current promotional and advertising materials. Maintains up to date knowledge of regulatory requirements and communicates changes in regulatory information to the project teams in a timely manner participate and represent regulatory affairs on the company\'s Actelion review committee and provide guidance to members of the ARC regarding current regulatory environment and regulatory considerations that may impact business activities.

For more information, please click here to visit us at PharmaceuticalCrossing

For further information, please visit us online at http://www.pharmaceuticalcrossing.com

Sign Up Now

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com