Valeant Pharmaceuticals

Director/Sr Director, Regulatory Affairs - Advertising and Promotion

US-NJ-Bridgewater
Job ID
4028
Pos. Category
R&D
Pos. Type
Full Time

Overview

The Senior Director of Advertising & Promotion prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs.  The Senior Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements

Responsibilities

Manages the Regulatory Promotional  reviewers for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products.  This position may require reviewing  promotional materials if the company requires it.  This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.

Provide guidance on proposed claims for products in development and development of ISI and brief summaries. 

Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP) and other regulatory considerations that may impact business.  Develop or revise procedures as needed.

Review packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.

Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.

 

Represents regulatory affairs  in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.

 

Interacts with Quality related to internal audits and CAPAs, as needed.

Qualifications

  • Bachelor degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
  • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Ability to work in a team environment
  • Working knowledge of Rx NDA development and approval process
  • Excellent communication skills; both oral and written
  • Fifteen+ plus years of relevant pharmaceutical experience with 10+ years of relevant regulatory affairs product advertising and promotion experience. Broad knowledge of the pharmaceutical industry.  Demonstrated ability to contribute to a continuous learning and process improvement environment.

Be Aware of Recruiting Fraud

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

 

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