Valeant Pharmaceuticals

Director, Regulatory Affairs (Consumer Ad/Promo and Labeling)

Job Location US-NJ-Bridgewater
Job ID
9915
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Director of advertising & promotion and labeling for consumer products manages and/or participates in the review and approval of advertising and promotional pieces and labeling for consumer products. This includes OTC drugs, nutritionals, cosmetics and devices. The Director is responsible for ensuring the pieces are in compliance with all applicable laws and regulations.
The Director is also responsible for managing the personnel who lead the development of labeling for consumer products, including OTC drugs, nutritionals, cosmetics and Class I and II devices.

Responsibilities

Manages the Regulatory promotional reviewers for consumer products who represent Regulatory Affairs on the promotional review committees. This position may also require the Director to review promotional materials if the company requires it. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives for consumer products.
Provides guidance and strategic support on proposed claims for products in development.
Regularly monitors the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at the FTC and FDA and other regulatory considerations that may impact business. Develop, revise and review procedures as needed.
Other job responsibilities as needed

 

Key relationships:

Represents regulatory affairs in cross functional consumer product promotional review teams as required, participates in development committees for processes and procedures relating to advertising and promotion, and consumer labeling.

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

Qualifications

• Bachelor’s degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
• Knowledge of promotional regulations for OTC NDA and monograph drug products, nutritional products and Class I and II devices
• 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
• Excellent communication skills, both oral and written

 

Experience:

Ten+ plus years of broad knowledge and experience of the pharmaceutical industry with 5+ years of relevant regulatory affairs consumer product advertising and promotion review experience. Supervisory experience. Knowledge of the OTC labeling regulations. Demonstrated ability to contribute to a continuous learning and process improvement environment.

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