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Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Richmond, Virginia
Industry:
Salary: Negotiable
Reference: MurfinAdPro_1495234398
Contact Name: Kyle Murfin
Contact Email: k.murfin@sciproglobal.com
Job Published: May 19, 2017 23:53

Job Description

Manager, Regulatory Advertising and Promotion - Richmond, VA

Note: For the right candidate, remote working will be considered.

The Manger, Regulatory Advertising and Promotion is a skilled regulatory manager with strong understanding of the FDA regulations associated with Ad/Promo 21 CFR Part 202.1 (Prescription Drug Advertising) and possesses excellent review and editing ability. Understanding safe and effective use of drug products for human consumption.

Responsibilities:

  • Maintain knowledge and understanding of FDA regulations and guidelines regarding drug product labeling.
  • Research and evaluate Advertisement and Promotional/labeling precedents for marketed drug products to help with guidance.
  • Monitor FDA regulations and guidelines for periodic changes, and assess the impact of regulatory changes on our client currently approved or planned product Ad/Promo pieces and relation to Rx product labeling.

Experience:

  • 3-5 years' experience in the pharmaceutical industry focused on Ad/Promo.
  • A comprehensive understanding of prescription drug products, medical writing, FDA regulations and guidance on Ad/Promo.
  • A minimum of 3-5 years of labeling quality and compliance with US regulations throughout the drug product label life cycle having been devoted to the development of final product labeling in the regulated pharmaceutical drug products with correlation to Advertisement and promotional pieces.

If this is a position you are interested in, please apply within, or email me at k.murfin@sciproglobal.com

Manager, Regulatory Advertising and Promotion - Richmond, VA

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