Associate Director, Regulatory Affairs

Date: Sep 22, 2022

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch Health

OBJECTIVES/PURPOSE OF JOB

The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.

 

KEY ACTIVITIES/RESPONSIBILITIES

  • Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
  • Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
  • Monitors FDA activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to PRC(s).
  • Trains regulatory staff as required.
  • Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate.
  • Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance.
  • Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
  • Assures that promotional PIs and Important Safety Information are updated as appropriate.
  •  Other job responsibilities as needed.

 

 

QUALIFICATIONS/TRAINING

  • Bachelor’s degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD] preferred)
  • Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency
  • Strong capability to work in a team environment
  • Strong business acumen and the ability to see business drivers outside of regulatory affairs
  • Working knowledge of the Rx product NDA and labeling processes
  • Previous course training in advertising and promotion and attendance at training conferences a plus
  • Excellent communication skills, both oral and written
  • Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner

 

EXPERIENCE

 

  • Minimum of 8 years of relevant pharmaceutical industry experience with 4+ years of relevant prescription product advertising and promotion review experience.  Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. 
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.