Executive Director, Regulatory,Law
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 Alcons products. This position will have frequent interactions with senior managers in Alcons 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. *
Executive Dir Regulatory Law
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.
12 Years of Relevant Experience.
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.
Fort Worth, TX
Legal & Intellectual Property & Compliance
NON-NVS AL LEGAL
Alcon Vision, LLC.
Alcon is an Equal Opportunity Employer and participates in E-Verify. 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, gender identity, 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 email to email@example.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If youd like to view a copy of the Alcons affirmative action plan or policy statement, please email firstname.lastname@example.org.
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.