Sr. Associate, Regulatory Affairs Strategy

Job description

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? Sr. Associate, Regulatory Affairs Strategy In this role, a typical day will include: · Support the development and execution of regulatory strategies and plans for new and marketed products, ensuring timely submissions, approvals, and lifecycle compliance in collaboration with Global Regulatory Affairs and cross-functional stakeholders. · Prepare and support submission of regulatory dossiers (as required) tailored to local requirements to facilitate efficient health authority review and approval. · Maintain all product and establishment licenses (e.g., marketing authorizations, import licenses) to ensure uninterrupted business continuity. · Maintain accurate regulatory records and databases (e.g., Veeva RIM), ensuring all product information and submission statuses are current and audit-ready. · Monitor regulatory changes, conduct regulatory impact assessments and gap assessments as needed, and support updates to internal policies, procedures, and documentation. · Engage with internal stakeholders and support interactions with Health Authorities to enable effective regulatory execution and alignment with business objectives. · Perform review and approval (as applicable) of local labeling, advertising, and promotional materials in compliance with applicable regulations and company standards. · Provide regulatory support for market actions (e.g., FSCAs, recalls) and related health authority communications. · Support initiatives to drive performance improvements and contribute to achieving performance targets and operational excellence. · Deliver timely responses to regulatory queries from stakeholders across the organization · Perform additional duties as required by the regional or affiliate QRA function. WHAT YOU’LL BRING TO ALCON: · BSc Degree in a Scientific or Engineering discipline or related field · Proven experience (at least 2 years) in Regulatory Affairs function in the medical device or pharmaceutical industry, including comprehensive knowledge of ISO13485 and/or similar · Very good command of English (written and spoken), Nordic language is considered a strong advantage · Experience working in an international environment · Excellent communication and interpersonal skills · Strong stakeholder management skills, with the ability to build effective relationships across different functions and levels of the organization HOW YOU CAN THRIVE AT ALCON: Collaborate with teammates to share standard processes and learnings as work evolves! Attractive benefits package (private medical care, group insurance, lunch card, transportation allowance, pension plan, Multisport/cultural card, Alcon products for you and your significant other) Employment contract, full‑time position Hybrid work (3/2/weekly) Modern office with many facilities inside located at NewCity building, 15 Marynarska Street, Warsaw Alcon Careers See your impact at alcon.com/careers ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker