Director, Regulatory Affairs

Director, Regulatory Affairs (7758)

Career Opportunities: Director, Regulatory Affairs (7758)

Requisition ID 7758 - Posted - US Ad/Promotion - R&D - US - Bridgewater, NJ - City (1)

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

JOB TI T LE

Director, Advertising and Promotion

BUSINESS TITLE

Director, Advertising and Promotion, Prescription Drug Products

BAND

EXE

BUSINESS UNIT /

FUNCTION

US Regulatory Affairs

JOB CODE

N/A

LOCATION

United States

OBJECTIVES/

PURPOSE OF JOB

The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are in compliance with all applicable laws, regulations, and regulatory agency guidance.

KEY ACTIVITIES/

RESPONSIBILITIES

Manages or represents Regulatory Affairs on the promotional review committees for prescription products to review promotional materials for compliance with regulatory requirements while meeting the Company's strategic promotional objectives.

Implements regulatory strategies and solutions to assure that all advertising and promotional materials are in compliance with regulatory requirements and Company policies.

Provides guidance and strategic support on proposed claims for products in development and helps develop Important Safety Information (ISI) and Brief Summary documents as appropriate.

Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance.

Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business.

Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.

Develops communication packages for regulatory advice, response to FDA action letters, and leads the company in discussions with OPDP and APLB.

Coordinates company-wide ongoing training on regulatory issues pertaining to product promotion. Other job responsibilities as needed.

SUPERVISE DIRECT

REPORTS

Yes

SCOPE OF POSITION

Manages strategic direction, training, and review of prescription drug product

advertising and promotion materials, for compliance with company policy and

regulatory agency requirements.

KEY RELATIONSHIPS

Represents Regulatory Affairs as required as an active key participant on cross

functional prescription product promotional review teams, consisting of members

from marketing, legal, medical and Regulatory Affairs.

Participates in development committees for processes and procedures related to

advertising and promotion.

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

QUALIFICATIONS/

TRAINING

• Bachelor’s degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD] highly preferred)
• Knowledge of regulations related to prescription drug promotion
• Previous course and/or conference training in advertising and promotion
• Working knowledge of Rx NDA and labeling development and approval process
• Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
• Strong interpersonal skills with the ability to influence, without authority, others in a positive and effective manner
• Ability to work in a team environment
• Excellent communication skills, both oral and written

EXPERIENCE

Minimum of 10 years of relevant pharmaceutical industry experience with 5 years of relevant Regulatory Affairs prescription product advertising and promotion review experience. Supervisory 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.

This position may be available in the following location(s): US - Bridgewater, NJ

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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

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Bausch Health is an EEO/AA employer M/F/D/V.