Principal Regulatory Affairs Specialist - Ad Promo

Job Opportunity at Bausch + Lomb

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from 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 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 include providing regulatory review and approval of advertising and promotional materials, new campaigns and launch strategies, implementing regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies, monitoring FDA and FTC activity, assuring timely and accurate review of advertising and promotional materials, monitoring competitor advertising, providing regulatory support for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges, continually assessing the advertising and promotion related process to enhance efficiencies, compliance and assist with ongoing regulatory training related to products, working closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion, and communicating with regulatory authorities on the companys behalf. Actively leads and / or participates in team activities.

Qualifications : Bachelor degree preferred or equivalent, minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment, 2+ years of ad / promo experience relevant to prescription drugs, dietary supplements, cosmetics and or OTC drugs, strong working knowledge of regulatory guidelines, development and commercialization of products, strong organizational skills and excellent in managing multiple priorities, excellent communication skills (oral and written), computer literacy Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility, ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy & increase probability of regulatory success, ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data, knowledge of current and emerging issues and trends, ability to communicate effectively with regulatory authorities on the companys behalf, strong interpersonal skills with the ability to influence others in a positive and effective manner, without authority, ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.

We offer competitive salary & excellent benefits including medical, dental, eye health, disability and life insurance begins on your hire date, 401K Plan with company match and ongoing company contribution, paid time off vacation, floating holidays and sick time, employee stock purchase plan with company match, employee incentive bonus, tuition reimbursement, ongoing performance feedback and annual compensation review.