Regulatory Operations - Regulatory Data Management

Regulatory Operations - Regulatory Data Management

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. Associate, Regulatory Operations (Professional Path) is primarily responsible for leading and completing compliance activities, including Change Control, Audit Management, and Quality Metrics. You will review regulatory documents and ensure adherence to audit schedules and regulations.

Specifics Include:

• Perform specialized tasks and conduct independent research to optimize outcomes for medical device and pharmaceutical products
• Handle dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling
• Maintain up-to-date databases of submissions and approvals
• Make decisions within the scope of assigned tasks to achieve project goals
• Apply advanced knowledge, analytical skills, and self-direction
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Contribute to the overall compliance of the organization and commit to continuous improvementAll 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​.

Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.