Director, Regulatory Affairs Operations & Publishing (Pharma) Job at Alcon in Fo

Director, Regulatory Affairs Operations & Publishing (Pharma) 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. 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. The Director of Regulatory Affairs (Management Path) is primarily responsible for directing product/process registration submissions and providing strategic product direction to teams. You will build effective relationships with regulatory agencies to expedite approvals and address inquiries. 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 SOPs, maintaining accurate documentation, and ensuring rigorous quality control Complete all required training and contribute to overall compliance through continuous improvement Qualifications Bachelor’s Degree or equivalent experience (or high school +18 yrs; Associate +14 yrs; M.S. +7 yrs; Ph.D. +6 yrs) Fluent in reading, writing, understanding, and communicating in English 10 years of relevant experience 6 years of demonstrated leadership Minimal travel Work location: Onsite – Fort Worth, TX (this role may be based at other Alcon locations, subject to business needs) Benefits Collaborate with colleagues to share standard methodologies and discoveries as work progresses Explore specific growth and development possibilities throughout your career Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight and lives Receive a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and more ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E‑VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives. Our policies are non‑discriminatory in recruitment, hiring, training, promotion, and other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. #J-18808-Ljbffr