Associate I, Regulatory Operations

About the Role

This role is part of Alcon's Quality & Regulatory Affairs function, ensuring products comply with global, local, and internal regulations and meet the strictest standards of quality.

Key Responsibilities

• Support project goals by handling regulatory submissions, maintaining databases, and ensuring compliance with external regulations.
• Prepare dossiers, manage submissions, and maintain Regulatory Affairs Archives.
• Apply specialized knowledge to perform tasks and achieve objectives.
• Handle operational aspects of regulatory submissions, ensuring timely and accurate submission of documents.
• Maintain up-to-date databases of submissions and approvals.
• Prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing, and labeling.
• Maintain Regulatory Affairs Archives and Tech File Administration.
• Follow procedures with decision-making authority, requiring job-related training, attention to detail, and reliability.
• Ensure products comply with external regulations, internal standards, and customer requirements.
• File product notifications, approval applications, and quality testing results with government and regulatory agencies.
• Interpret proposed regulations and advise management on their impact.
• Implement and audit compliance processes.
• Provide guidance to development and marketing teams on product changes, quality testing, labeling, literature, and advertising.
• Adhere to Good Practice (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 compliance of the organization.
• Commit to continuous improvement in operations.

Qualifications

• Shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.
• Adherence to GxP regulations:
• Strictly follow Standard Operating Procedures (SOPs).
• Maintain accurate and complete documentation.
• Ensure rigorous quality control.
• Complete all required training.