Bausch + Lomb Senior Manager, Regulatory Affairs in South Boston, Massachusetts
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
The Senior Manager, Advertising and Promotion, Prescription Drug Products reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.
Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies.
Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and Company policies.
Monitors FDA activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on Company products and communicates risk to PRC(s).
Assurestimely andaccuratereviewof advertisingandpromotionalmaterialto meet internal timelines and requirements.
Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
Continually assesses the advertising and promotion related process to enhance efficiencies and compliance, and assist with ongoing regulatory training related to prescription drug products.
Works closely with the Regulatory Affairs prescription drug product labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.
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.
Ability to work in a team environment.
Working knowledge of the Rx product NDA and labeling processes.
Previous course training in advertising and promotion a plus.
Excellent communication skills; both oral and written.
Stronginterpersonalskillswith theabilitytoinfluenceothers,withoutauthority, in a positive and effective manner.
Minimum 6 years of relevant pharmaceutical industry experience with 3+ years of relevant pharmaceutical advertising and promotion experience.
Knowledge of the pharmaceutical industry Regulatory Affairs Discipline for prescriptions drugs
Demonstrated ability to contribute to a continuous learning and process improvement environment.
This position may be available in the following location(s): [[location_obj]]
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.
To learn more please readBausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .
Our Benefit Programs: https://www.bausch.com/careers/benefits/
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