Senior Manager, Regulatory Affairs Ad Promo / Regulatory Strategy

Alcon•Fort Worth, TX

4d•Onsite

About The Position

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.

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