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Senior Associate, Regulatory Affairs Strategy

alcon · Warszawa

New
Senior 🇬🇧 English
Veeva RIM

Job description

About the role

Alcon is seeking a Senior Associate to support regulatory strategy and execution for new and existing eye‑care products. You will work closely with Global Regulatory Affairs and cross‑functional teams to ensure timely submissions, approvals, and lifecycle compliance.

Key responsibilities

  • Develop and execute regulatory strategies and plans for new and marketed products.
  • Prepare and submit regulatory dossiers tailored to local requirements.
  • Maintain product and establishment licenses to ensure business continuity.
  • Keep regulatory records and databases (e.g., Veeva RIM) audit‑ready.
  • Monitor regulatory changes, conduct impact assessments, and update internal policies.
  • Support interactions with Health Authorities and internal stakeholders.
  • Review and approve local labeling, advertising, and promotional materials.
  • Provide regulatory support for market actions such as recalls and FSCAs.

Required profile

  • BSc in a scientific or engineering discipline.
  • At least 2 years of regulatory affairs experience in medical devices or pharmaceuticals.
  • Strong command of English; knowledge of a Nordic language is a plus.
  • Experience working in an international environment.
  • Excellent communication, interpersonal and stakeholder management skills.

Required skills

  • Knowledge of ISO 13485 (or equivalent).
  • Experience with Veeva RIM or similar regulatory information systems.

What we offer

  • Private medical care, group insurance, lunch card, transportation allowance, pension plan.
  • Multisport/cultural card and Alcon products for you and your partner.
  • Full‑time permanent contract with modern onsite office at NewCity building, 15 Marynarska Street, Warsaw.

Questions fréquentes

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Source : ats:workday

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Published 5 hours ago

Expires 1 month from now

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alcon

Warszawa