Senior Manager, Regulatory Affairs Ad Promo / Regulatory Strategy

Alcon • Fort Worth, TX

3d • Onsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, 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 make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon'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 related 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 related 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 current promotions and advertising. Oversee 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-related 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 Develop 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, progress 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

Requirements

• Bachelor’s Degree or Equivalent years of directly related 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

Responsibilities

• 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 related 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 current promotions and advertising.
• Oversee 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-related 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
• Develop 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, progress 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

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1-10 employees