Senior Director, Regulatory Affairs CMC

Alcon Research • Fort Worth, TX

8d • Onsite

About The Position

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:

Requirements

• Bachelor’s Degree
• The ability to fluently read, write, understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership

Responsibilities

• 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

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees