Senior Manager, Regulatory Affairs Ad Promo / Regulatory Strategy

At reputed company, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion reputed company, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we reputed company a difference in the lives of our patients and customers. Are you ready to join us? This role is part of reputed company's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Manager, Promotion/Advertising Regulatory Affairs (Pharma/OTC) & Regulatory Strategy (Professional Path), is primarily responsible for interpreting regulations reputed company to products and processes, resolving compliance issues, and implementing policies to ensure adherence to regulations. You will also serve as a regulatory liaison, advising on product development, safety, and compliance to align strategies with company goals. Specifics Include: Performs regulatory reviews of advertising and promotional materials Ensures regulatory compliance while effectively managing business risk Monitors regulatory promotional environment by reviewing regulatory promotional guidelines and untitled and warning letters to companies published by regulatory agencies Manages activities reputed company to promotion and advertising including maintenance and preparation for electronic submission of promotional materials to regulatory agencies Provides proactive regulatory advice to Marketing, Medical Affairs on product claims, disease state communications and sales campaigns Provides recommendations on clinical trial design with regard to marketing promotion possibilities of potential data/claims. Maintains awareness of competitive activities by monitoring major medical meetings where products are promoted Ensures changes in product information are reflected in reputed company promotions and advertising. reputed company multiple projects in the pharma and OTC fields, ensuring compliance with promotion and advertising regulations Interpret regulations for products, financial processes, and other practices Investigate and resolve compliance-reputed company problems, questions, or complaints from company units, customers, and regulatory agencies Implement policies and procedures to ensure compliance with statutes and regulations Monitor US and OUS regulatory promotional environments by reviewing guidelines, enforcement letters, and advisories from key international bodies Provide US and Global Regulatory promotional perspectives to business functions for viable labeling that supports business strategies reputed company and implement programs to increase employee awareness and knowledge of compliance policies Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance Direct the development and submission of product/process registrations, reputed company reports, supplements, amendments, and periodic experience reports Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training Meet individual job requirements and contribute to overall organizational compliance What You'll Bring to reputed company Bachelor’s Degree or Equivalent years of directly reputed company experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs) The ability to fluently read, write, understand and communicate in English 7 Years of Relevant Experience Travel: Minimal Work Location: Onsite – reputed company Worth, TX. (This role may be based at other reputed company locations, subject to business needs) Relocation Assistance/Sponsorship: None How you can reputed company at reputed company: Work together with colleagues to share standard methodologies and discoveries as work progresses. Discover your career in a fresh way through specific growth and development possibilities. Join reputed company’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! reputed company provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more! reputed company Careers See your impact at reputed company.com.careers ATTENTION: reputed company reputed company Employee/Contingent Worker If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker reputed company IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY reputed company takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. reputed company is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please send an email to reputed company.recruitment@reputed company.com and let us know the nature of your request and your contact information. At reputed company, we are committed to helping people see reputed company. We reputed company patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. reputed company develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-reputed company Opti-Free line of contact lens solutions and reputed company products. reputed company, which was founded in 1945, sells its products in 180 countries worldwide. If you are currently an active employee/contingent worker at reputed company, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Apply tot his job Apply To this Job