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 Director, Regulatory Affairs Strategy (NPD/OH) (Management Path) is primarily responsible for directing product registration, providing strategic guidance, and negotiating with regulatory agencies to ensure timely product approvals. You will serve as a regulatory liaison, advising on product development, safety, and compliance while leading a department to align strategies with company goals.
Specifics Include:
- Lead a team within the Regulatory Affairs developing and implementing strategies for success and alignment with company goals.
- Lead preparation of global regulatory plans and product strategies for assigned products.
- Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports.
- Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies.
- Ensure rapid and timely approval of products and their continued approval.
- Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities.
- Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies.
- Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations.
- Oversee regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals.
- Provide regulatory strategies and risk assessments/mitigation plans for new product introductions and product changes, maintaining regulatory compliance.
- Support products in the medical device and/or pharmaceutical family, ensuring adherence to relevant regulations.
- Ensure compliance with Good Practice (GxP) regulations, Standard Operating Procedures (SOPs), and quality control, maintaining accurate documentation and completing required training.
- Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions.
- Focus on talent development to enhance capabilities.
- Manage post-approval commitments and lifecycle management.
- Lead and supervise regulatory associates, ensuring synergy across projects and driving competitive advantage through strategic decision-making.
- 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.
What You'll Bring to Alcon
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
- The ability to fluently read, write, understand and communicate in English
- 10 Years of Relevant Experience
- 6 Years of Demonstrated Leadership
- Travel: Minimal
- Work Location: Onsite – Fort Worth, TX
- Relocation Assistance/Sponsorship: None
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
See your impact at alcon.com.careers
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Employees
Find Jobs for Contingent Worker
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.