Senior Director, Regulatory Affairs Strategy & BD&L

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 Strategy (Management Path) is primarily responsible for developing and driving strategies for Quality and Regulatory oversight of Alcon Affiliate sites in the LACAR Region. You will lead product registration, maintain medical device licenses, and ensure quality oversight while collaborating with global regulatory, clinical, and R&D teams.

Specifics Include:

• Lead multiple departments or a large division within the Regulatory Affairs team, providing strategic leadership and ensuring compliance with regulatory requirements
• Leads preparation of global regulatory plans and product strategies for assigned products.
• Manage and provide regulatory support on business development and licensing activities that aligns with corporate strategy.
• Manage and participate in conducting regulatory due diligence activities.
• 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, and ensure rapid and timely approval of products and their continued approval
• 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 by coordinating between plants, agents, and continuously communicating with all parties involved to ensure timely submission and approvals
• Provide regulatory strategies and risk assessments/mitigation for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
• Support products in either the medical device and/or pharmaceutical 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 to ensure synergy across projects, driving competitive advantage through strategic decision-making, and the overall business outcomes
• Focus on talent development to enhance capabilities.
• 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 .
  
  

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: Minimal
• Work Location: Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
• 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

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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.