Director US Regulatory Affairs Ad & Promo

Provides strategic regulatory advice on professional and Direct to Consumer (DTC) advertising and promotion materials, and activities for assigned products, in accordance with business goals and objectives, under US FDA requirements and company policy,

Serves as primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) teams for assigned products. Liaison with FDA's CDRH, including response to agency inquiries and company requests for advisory comment, as applicable. Establishes strong and positive working relationships with CDRH staff. Develops solutions to complex US promotional issues by utilizing scientific, regulatory, and therapeutic areas knowledge to support business objective and initiatives, while effectively managing business risks. Works closely with business partners to ensure regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising can be based, and that planned pre- and Phase IV post-approval studies will support desired US promotional claims. As appropriate, prepares compliant letters to competitors or other regulatory bodies; working with PRC partners. Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities. Ensures changes to the US labeling are appropriately implemented into product promotional materials. Ensures active participation on industry association committees, such as AdvaMed, to positively influence the advertising and promotion environment for Alcon products. Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations and guidance, relevant enforcement action (warning and untitled letters), and general awareness of industry practices, including those of competitors.

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon 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 perform the essential functions of a position, please send an e-mail to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information
Posting Title
Director US Regulatory Affairs Ad & Promo

Minimum requirements
Bachelor's required
English
10 years directly related experience
Class 3 Med Device experience preferred
Med Device promotional review experience
Healthcare/Med Device Industry experience

Job Type
Full Time

Country
USA

Work Location
Fort Worth, TX

Functional Area
Research & Development

Division
ALCON

Business Unit
RESEARCH & DEVELOPMENT AL

Employment Type
Regular

Company/Legal Entity
Alcon Laboratories, Inc.

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


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