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. Director, Regulatory Affairs - External Ocular Devices (Management Path) is primarily responsible for developing and driving regulatory strategies for various product portfolios. You will oversee new product registrations and maintenance of those registrations throughout the product lifecycle, while collaborating with global regulatory, marketing, clinical, manufacturing and R&D teams. Specifics include:
- Strategically lead Regulatory Affairs team, ensuring compliance with regulatory requirements.
- Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports.
- Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, ensure rapid and timely approval of products and maintain approval throughout the product lifecycle.
- Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations.
- Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates to ensure timely submission and approvals.
- Oversee creative and innovative approaches to competitive claims development and labeling, advertising and promotional material review and approval for product portfolios, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations.
- Proactively monitor and evaluate the US and OUS regulatory promotional environment by reviewing guidelines, enforcement letters, advisories from key international bodies and attending major industry meetings. Use this intelligence to inform promotional claim strategies.
- Provide US and Global Regulatory promotional perspective to business functions to ensure commercially viable labeling supporting business strategies.
- Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage.
- Support products in either the medical device and/or pharmaceutical/OTC family of products, ensuring adherence to all relevant regulations.
- Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments and overall business outcomes.
- Oversee regulatory assessment and acquisition/integration strategy for all merger and acquisition (M&A) activities.
- Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
- Contribute to the overall compliance of the organization and commit to continuous improvement in operations. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
- Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
- This role will support the External Ocular devices portfolio.
What You'll Bring to Alcon
- Bachelor’s Degree
- The ability to fluently read, write, understand and communicate in English
- 12 Years of Relevant Experience
- 8 Years of Demonstrated Leadership
- Travel: 20% Domestic and International
- Work Location: Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
- Relocation: Yes
How you can thrive at Alcon:
- Work together with colleagues to share standard methodologies and discoveries as work progresses.
- Discover your career in a fresh way through specific growth and development possibilities.
- Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
- Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
Alcon Careers
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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY
Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory 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 email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.