Senior Associate Regulatory Affairs Strategy
Alcon
Fribourg, Switzerland
Full-Time
$3
OfficeSenior
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. The Sr. Associate I, Regulatory Affairs Strategy (Professional Path) is primarily responsible for ensuring product compliance with regulations, and maintaining product registrations. You will build effective relationships with internal collaborators and regulatory authorities to support strategic decisions and compliance.
Represent the Regulatory Affairs function at the country/cluster level, supporting compliance with applicable national and international regulations for Alcon marketed products. The role contributes to the execution of defined regulatory strategies and ensures timely and compliant regulatory activities under appropriate supervision.
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.
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.
WHAT YOU’LL BRING TO ALCON:
BSc Degree in a Scientific or Engineering discipline or related field
English and German are mandatory; French is an asset.
Proven experience (at least 2 years) in Regulatory Affairs function in the medical device and/or pharmaceutical industry, including comprehensive knowledge of ISO13485 and/or similar.
HOW YOU CAN THRIVE AT ALCON:
● Manage your own workload and schedule while hitting your set targets
● Collaborate with teammates to share best practices and learnings as work evolves
● See your career like never before with focused growth and development opportunities
Alcon Careers
See your impact at alcon.com/careers
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If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.