Senior Director, Regulatory Affairs CMC

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, Chemistry Manufacturing & Control (CMC) (Management Path) is primarily responsible for shaping and leading the execution of global CMC regulatory strategies for biologics, pharmaceuticals, and combination products across Alcon’s global portfolio. You will lead CMC submissions, strategically engage with health authorities, and guide the team in assessing regulatory challenges. You'll also proactively identify risks, develop solutions, and guide company policies on regulations.

Specifics include:

• Lead development and implementation of global CMC regulatory practices and strategies to support product development throughout the lifecycle of biologics, pharmaceuticals, and combination products maintaining regulatory compliance to drive competitive advantage
• Design and direct the development of Regulatory Affairs CMC team and capabilities to streamline regulatory support for CMC related projects and activities
• Oversee all of Alcon’s global CMC submissions, including initial market registrations, progress reports, supplements, amendments, and annual reports
• Represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions
• Proactively identify risk areas, develop alternative courses of action, and assess the impact of new regulations to prepare the team to implement necessary changes
• Lead the development of company policy and positions on draft regulations and guidance
• Demonstrate strategic thinking, advanced regulatory knowledge, excellent communication, leadership, and problem-solving abilities
• Oversee and serve as primary decision-maker for CMC regulatory assessment and acquisition/integration strategy for business development and licensing activities
• Attract, retain and develop Regulatory Affairs CMC talent
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Meet individual job requirements and contribute to overall organizational compliance while committing to continuous improvement and compliance with regulatory requirements
  
  

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.