Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist - Ad PromoBausch + Lomb 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 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 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.Objectives:Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations.Responsibilities:Provides regulatory review and approval 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 and FTC activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on Company products and communicates risk to Promotional Review Committee (PRC).Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.Monitors competitor advertising to keep abreast of market promotional and advertising strategies.Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges.Continually assesses the advertising and promotion related process to enhance efficiencies, compliance and assist with ongoing regulatory training related to products.Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.Communicate with regulatory authorities on the companys behalf.Actively leads and/or participates in team activities.Qualifications:Bachelor degree preferred or equivalentMinimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment2+ years of ad/promo experience relevant to prescription drugs, dietary supplements, cosmetics and or OTC drugsStrong working knowledge of regulatory guidelines, development and commercialization of productsStrong organizational skills and excellent in managing multiple prioritiesExcellent communication skills (oral and written)Computer Literacy Microsoft Package including Word, Excel, and Outlook; Adobe AcrobatEntrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibilityAbility to take innovative ideas from proof of concept to promote a successful product regulatory strategy & increase probability of regulatory successAbility to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by dataKnowledge of current and emerging issues and trendsAbility to communicate effectively with regulatory authorities on the companys behalfStrong interpersonal skills with the ability to influence others in a positive and effective manner, without authorityAbility to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlinesWe offer competitive salary & excellent benefits including:Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date401K Plan with company match and ongoing company contributionPaid time off vacation (3 weeks - prorated upon hire), floating holidays and sick timeEmployee Stock Purchase Plan with company matchEmployee Incentive BonusTuition Reimbursement (select degrees)Ongoing performance feedback and annual compensation reviewAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.