Executive Director Regulatory Law
- Fort Worth, TX
This position will be responsible for providing medical device and drug law-related legal support on regulatory issues relating the approval, manufacturing and marketing of Alcon's products. This position will have frequent interactions with senior managers in Alcon's commercial, regulatory, and quality functions.
• Serve as a subject matter expert on medical device and drug law matters relating to product approval, GxP compliance, safety reporting, and promotional requirements.
• As needed, directly advise senior management (ELT, ELT-1) on high-profile medical device and drug law matters, including market actions, interactions with FDA on enforcement matters, emerging changes to or interpretations of the Food, Drug and Cosmetic Act, and challenges involved with product regulatory reviews.
• Serve as the primary Legal point of contact to the global QA, Regulatory Affairs, Pharmacovigilance and Medical Device Vigilance teams.
• Serve as a primary Legal point of contact on clinical trial contracting matters for the Global R&D and US Medical Affairs teams, including any Legal input on Alcon-sponsored Clinical Study Agreements and Alcon-supported Investigator-Initiated Trials.
• Serve as a resource to the BD&L teams to support due diligence, negotiations, and drafting of terms relating to food and drug law matters.
• Manage outside regulatory counsel to ensure that Alcon receives timely, efficient and effective legal advice and representation.
*Relocation assistance is available. *
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.
• Law degree and bar admission, or license to practice law in a relevant jurisdiction.
• The ability to fluently read, write, understand and communicate in English.
• Prior scientific or technical training is a plus.
• 12 years of relevant experience to include 10+ years of professional experience working for a top law firm, FDA, or in a comparable regulatory law in-house role at a medical device (preferably) or pharmaceutical company.
•Comprehensive knowledge of FDA laws and regulations of medical devices, OTC products, and drugs, is required.
•Significant experience in two or more of the following substantive areas is strongly preferred:
o FDA requirements relating to prescription and OTC drugs, medical devices, and cosmetics.
o State laws and regulations associated with the distribution of medical devices and regulations.
o Laws, regulations, and current case law regarding the advertising and promotion of medical devices, OTC products, and drugs.
o Contracting requirements for clinical studies.
o Anti-kickback/anti-bribery requirements.
o Medical device and/or pharmaceutical reimbursement.
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