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Manager, Regulatory Affairs
SRG Woolf Group
- Clinical Operations
Our client, pharmaceutical company near the Los Angeles metro area is seeking a Manager, Regulatory Affairs-Labeling to join their team. This is a fantastic opportunity with a global sponsor. If you are looking for a new consulting project that will allow you to utilize your Regulatory Affairs, Labeling knowledge and Submissions and FDA regulations experience then this is an opportunity to explore.
PURPOSE OF POSITION: The Manager, Regulatory Affairs will be responsible for meetings with regard to assigned marketed or development products as well as provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets, FDA regulations, and FDA guidance. In addition this role will manage outside vendor conversion of package inserts and convert existing package inserts into Physician Labeling Rule (PLR) format, as needed. Coordinate preparation of regulatory labeling submissions initiated by Regulatory Affairs with contributing functions in other departments.
EDUCATION/SKILLS: Bachelor’s degree in a related scientific discipline with a minimum of 4 years related experience within a pharmaceutical company, CRO or similar organization or Masters, PharmD or PhD with minimum of 2 years’. Experience drafting/reviewing product labeling and compiling supportive documentation as well as demonstrated competence in marketed product labeling maintenance. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
SRG Woolf Group is an Equal Employment Opportunity Employer. People from racial minority groups, veterans, and the disabled are strongly encouraged to apply.
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