Sr. Associate, Regulatory Affairs Strategy

Alcon MX; Warszawa; On-site; PLN 120,000 - 160,000; Full time

Benefits offered by this job

Private medical care

Group insurance

Lunch card

Transportation allowance

Pension plan

Multisport/cultural card

Alcon products for employees

Job summary

Alcon is looking for a Sr. Associate in Regulatory Affairs Strategy to join their team in Warsaw. You will support the development and execution of regulatory plans, ensuring compliance with local and global standards.

The ideal candidate has at least 2 years of experience in the Regulatory Affairs function within the medical device or pharmaceutical industry and possesses a BSc in a related field. The role includes maintaining regulatory records, engaging with Health Authorities, and driving

Qualifications

• At least 2 years of experience in Regulatory Affairs in medical device or pharmaceutical industry.
• Strong knowledge of ISO13485 and similar standards.
• Experience working in an international environment.

Responsibilities

• Support development and execution of regulatory strategies for products.
• Prepare and submit regulatory dossiers tailored to local requirements.
• Maintain licenses and ensure compliance for business continuity.
• Engage with stakeholders and Health Authorities for effective regulations.

Skills

Regulatory Affairs

Stakeholder management

Communication skills

English proficiency

ISO13485 knowledge

Education

BSc Degree in Scientific or Engineering discipline

Tools

Veeva RIM

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!

• 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

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti‑Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.