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Alcon · 1 month ago

Director, Regulatory Affairs Operations & Publishing (Pharma)

Fort Worth, Texas

Full-time

Onsite

Director/Executive

10+ years exp

Alcon is a company dedicated to enhancing sight and improving global eye health. The Director, Regulatory Affairs Operations & Publishing is responsible for directing product registration submissions and providing strategic direction to teams while ensuring compliance with regulations and quality standards.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Lead and mentor teams in dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling

Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and facilitate its rollout to cross-functional teams

Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions

Develop and implement strategies to ensure departmental success and alignment with company goals

Develop and maintain standard operating procedures (SOPs) for regulatory processes and manage regulatory filing systems

Oversee submission planning, formatting, publishing, and archiving

Make key decisions impacting department performance and success

Ensure timely and accurate submission of regulatory documents

Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and ensuring rigorous quality control

Complete all required training and contribute to the overall compliance of the organization by committing to continuous improvement and adherence to 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