About this role
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
- ON - SITE WORK
- Modern office with many facilities inside located at NewCity building, 15 Marynarska Street, Warsaw
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