At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Manager, Regulatory CMC supporting the Regulatory Affairs Team in Fort Worth, TX, a typical day will include:

• Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices.
• Prepares and directs the development of CMC submissions including initial market registrations, progress reports, supplements, amendments, and/or periodic experience reports.
• Interacts and negotiates with regulatory agencies in order to expedite approval of pending registration and answer any questions.
• Participates in the identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance.
• Develop and implement global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices.
• Prepare and direct CMC submissions, including initial market registrations, progress reports, supplements, amendments, and periodic experience reports.
• Represents the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions.
• Identify risk areas, develop alternative courses of action, and assess the impact of new regulations 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.
• 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.

Please refer the Job description for details