HCR0003245
Title: Manager, Regulatory Affairs Advertising and Promotion
Duration: 6 month contract
Pay : 60-80/HR on W2.
Location: Either in the Raleigh, NC office or remote
20 hours per week, timing TBD
Represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and possess a thorough knowledge of regulations for advertisement and promotional compliance governing device products (drug product experience acceptable) and the ability to translate regulatory requirements into decision-ready guidance for stakeholders. MUST have the education and experience to be able to review and conduct analysis independently in order to assist with the team's workload.
Bachelors degree minimum. 5 years or more DIRECT experience reviewing Advertising and Promotional pieces for the US market. It is NOT acceptable to only have experience in Regulatory Affairs in general.
Kindly share resume with answer:
Q1: How many yers of direct Regulatory Advertising & Promotion review experience for the U.S. market?
Q2: How many years of exp do you independently have reviewing FDA-regulated promotional and advertising materials?
Q3: Which products have you supported A: Medical Devices B: Pharmaceuticals
Q4: Have you served as the Regulatory representative on a Promotional Review Committee (PRC)?
Q5: Have you participated in Scientific Review Committee (SRC) or Medical Legal Regulatory (MLR) reviews?