About Us : Bausch + Lomb is a premier global eye health company committed to enhancing and protecting vision for millions worldwide. Our mission is straightforward yet impactful : helping you see better, to live better.
With a rich history of 170 years, our extensive portfolio includes over 400 products, catering to various eye health needs throughout life. Our global workforce of approximately 13,000 employees operates in around 100 countries, ensuring we reach billions of potential customers.
Position Overview : We are seeking a Lead Regulatory Affairs Specialist for Advertising and Promotion. This role is pivotal in ensuring that all promotional, educational, and training materials adhere to applicable laws and regulations.
Key Responsibilities :
- Conduct comprehensive regulatory review and approval of advertising, promotional materials, and new campaign strategies.
- Develop and implement regulatory strategies to ensure compliance with requirements and company policies.
- Monitor FDA and FTC activities, including enforcement actions and guidance documents, analyzing their impact on our products.
- Guarantee timely and accurate reviews to align with internal timelines and stakeholder needs.
- Review competitor advertising to stay informed of market strategies.
- Provide regulatory support for FDA warning and untitled letters, FTC communications, and competitor challenges.
- Enhance efficiencies in advertising and promotion processes and support ongoing training.
- Collaborate with the Regulatory Affairs labeling team to assess the implications of proposed labeling changes on product promotion.
- Serve as a communication link with regulatory authorities on behalf of the company.
- Lead and participate actively in team activities.
Qualifications :
Bachelor's degree preferred or equivalent experience.Minimum of 6 years in Regulatory Affairs or a related regulated environment.At least 2 years of experience in advertising and promotion relevant to prescription drugs, dietary supplements, cosmetics, or OTC drugs.Strong understanding of regulatory guidelines, product development, and commercialization.Exceptional organizational skills for managing multiple priorities.Outstanding oral and written communication abilities.Proficiency in Microsoft Office Suite and Adobe Acrobat.Entrepreneurial mindset with a focus on customer satisfaction and urgency.Capability to translate innovative concepts into effective regulatory strategies.Ability to critically evaluate scientific data and ensure clarity and support for conclusions.Awareness of current and emerging industry trends.Strong interpersonal skills for influencing others positively without direct authority.Skill in prioritizing and coordinating multiple projects under tight deadlines.What We Offer :
Competitive salary with excellent benefits, including medical, dental, eye health, disability, and life insurance starting from your hire date.401K plan with company match and ongoing contributions.Generous paid time off, including vacation (3 weeks prorated upon hire), floating holidays, and sick time.Employee Stock Purchase Plan and incentive bonuses.Tuition reimbursement for select degrees.Regular performance feedback and annual compensation reviews.All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
This position is based in our facility located at [insert precise work address].
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