Bausch Health Associate Director, Regulatory Affairs in Boston, Massachusetts
Associate Director, Regulatory Affairs (8923)
Career Opportunities: Associate Director, Regulatory Affairs (8923)
Requisition ID 8923 - Posted - Regulatory Affairs - R&D - US - Remote - City (7)
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.
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.
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
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.
This position may be available in the following location(s): US - Remote
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.
Bausch Health is an EEO/AA employer M/F/D/V.
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