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Regulatory Affairs Specialist

hace 1 mes

Barcelona, Barcelona, España Alk-Abelló AS A tiempo completo
Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Alk-Abelló A/S. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth submission of CMC documentation for Marketing Authorisation Applications, Variations, and Renewals.

Key Responsibilities:

  • Coordinate and prepare submission of CMC documentation for Marketing Authorisation Applications, Variations, and Renewals.
  • Ensure compliance with local and regional regulatory requirements.
  • Collaborate with cross-functional teams to ensure regulatory strategies are aligned with business objectives.
  • Provide regulatory support to other functional areas and sites.

Requirements:

  • 3+ years of experience in regulatory affairs, preferably in a pharmaceutical company.
  • Fluent in English, with experience in writing technical/scientific documentation.
  • Knowledge of the European Regulatory Environment and CTD guidelines.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

How to Apply:

Please submit your CV and application through our website. We look forward to hearing from you