Manager, Regulatory CMC

Alcon•Fort Worth, TX

1d•$105,000 - $175,000•Onsite

About The Position

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 Manager, Regulatory Affairs CMC supporting the Global Regulatory Affairs Team in Fort Worth, TX or Lake Forest, CA, a typical day will include: Implements global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. Contributes to the development of CMC submissions, including initial market registrations, progress reports, supplements, amendments, and periodic experience reports. With guidance, may represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions. Participates in identification of risk areas, develop alternative courses of action, and assess the impact of new regulations to implement necessary changes. Contributes to the development of company policy and positions on draft regulations and guidance. Demonstrate credible regulatory knowledge, excellent communication, 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. 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.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience
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.

Responsibilities

Implements global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices.
Contributes to the development of CMC submissions, including initial market registrations, progress reports, supplements, amendments, and periodic experience reports.
With guidance, may represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions.
Participates in identification of risk areas, develop alternative courses of action, and assess the impact of new regulations to implement necessary changes.
Contributes to the development of company policy and positions on draft regulations and guidance.
Demonstrate credible regulatory knowledge, excellent communication, 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.