Associate I, Regulatory Operations

Associate I, Regulatory Operations

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.

This Associate I, Regulatory Operations (State Licensing) is primarily responsible for supporting U.S. state licensing activities by assisting with regulatory filings, maintaining licensing databases and records, monitoring deadlines, and supporting compliance with applicable federal and state requirements. This role supports the preparation and submission of licensing applications, renewals, amendments, and related filings, while maintaining State Licensing archives and documentation.

Specifics Include:

• Apply specialized knowledge to support activities associated with U.S. state regulatory agencies and licensing requirements.

• Perform routine administrative activities, including data entry, record maintenance, document preparation, and filing support within State Licensing systems and databases.

• Support the preparation and submission of applications, renewals, amendments, discontinuations, and other state regulatory filings.

• Collect, organize, maintain, and distribute licensing records, state license certificates, submission documentation, and approval records within the State Licensing databases, archives, and tracking systems.

• Monitor licensing deadlines, regulatory requirements, and submission statuses to support timely and compliant filings.

• Partner with Regulatory Affairs, Legal, Quality, Supply Chain, Commercial Operations, and other cross-functional stakeholders to obtain information necessary to support licensing activities.

• Research regulatory requirements and support internal communications regarding potential business impacts.

• Support established processes to help maintain compliance with applicable federal and state regulations, including DSCSA, PDMA, FDCA, and state licensing requirements across all 51 U.S. jurisdictions.

• Identify and support opportunities to improve licensing processes, operational efficiency, data quality, and compliance systems.

• Demonstrate strong attention to detail, accountability, and reliability while executing assigned responsibilities.

• Adhere to applicable Good Practice (GxP) regulations and company standards by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and completing all required training.

• Meet individual performance expectations while contributing to the overall compliance objectives of the organization.

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​.

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.

Experience Level

Mid Level