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Regulatory Affairs Senior Analyst

Viatris · San Jose

Senior 🇬🇧 English

Job description

About the role

VIATRIS™ is seeking a Regulatory Affairs Senior Analyst to lead and coordinate in‑country product registration activities in Costa Rica. The role supports the Regulatory Affairs Manager and ensures compliance with local regulations, timelines, and internal SOPs.

Key responsibilities

  • Coordinate and follow up on product registrations to achieve timely approvals according to the registration plan.
  • Manage packaging artwork development in partnership with Logistics, Marketing and suppliers, respecting legal timelines.
  • Maintain registration licenses, regulatory information systems, correspondence and documentation for easy retrieval.
  • Support the Regulatory Affairs Manager with BAU activities, escalation of critical issues, and implementation of new procedures.
  • Handle correspondence with overseas and local parties to obtain or provide required documents.
  • Participate in meetings with BoH and trade associations and stay updated on current regulatory legislation.
  • Coordinate special projects and ensure system maintenance according to SOPs.
  • Collaborate with Quality and Supply to guarantee packaging, product appearance and specifications meet regulatory approvals.

Required profile

  • Pharmacist degree.
  • Minimum 3 years of regulatory affairs experience, preferably in pharma.
  • Proven ability to deliver on time, cost and quality standards.
  • Fluent written and spoken English.
  • Experience across drug discovery, development and commercialization lifecycle.
  • Knowledge of NDA submission processes and product life‑cycle management.
  • Ability to manage regulatory issues in a complex matrix environment.

Required skills

    What we offer

    • Competitive salary and benefits.
    • Inclusive work environment.

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    Published 3 weeks ago

    Expires 1 month from now

    38 views · 0 interested

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    Viatris

    San Jose