Subject Matter Expert, Regulatory Affairs, Promotion, Advertising, & Labeling

New Jersey
12 Dec 2017
01 Apr 2018

Subject Matter Expert, Regulatory Affairs, Promotion, Advertising, & Labeling

New Jersey

Job Description:

The person in this role is responsible for overseeing the regulatory assessment of external communications. He/she is accountable for thoroughly reviewing and assessing proposed external communications to evaluate their completeness, accuracy, and compliance with regulatory requirements for promotional materials for marketed and pipeline products. Additionally, he/she will provide regulatory input to various functional units on promotional labelling for marketed and to-be marketed drugs.


Essential Functions:

  • Provide regulatory guidance to the marketing team during the development, review and approval of product labelling and advertising materials
  • Assist the Director of Regulatory Services in regulatory oversight related to advertising and promotional activities
  • Provide guidance and Participate in training of sales and marketing personnel on promotional, marketing, labelling and advertising regulations
  • Provides effective solutions to mitigate identified regulatory risks
  • Provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved
  • Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed
  • Maintains a thorough understanding of OPDP requirements, as well as a keen awareness of enforcement trends
  • Oversee the compilation and submission of materials to Regulatory Authorities (e.g. OPDP) as applicable
  • Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising


  • Bachelors Degree (B.S.) in a life sciences or technical field from an accredited university and a minimum of seven (7) years related experience in Regulatory Affairs.
  • At least five (5) years of experience involving the direct implementation of promotional labelling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.


  • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and tactful negotiation skills
  • Proficient in excel, word, ppt, MS project

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!


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