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Regulatory Affairs Specialist

hace 2 meses

Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global pharmaceutical regulations and managing the creation and maintenance of labelling documentation.

Key Responsibilities
  • Participate in the preparation and revision of informative texts for healthcare professionals and patients, including SmPC, PIL, and labelling, for EU and non-EU markets.
  • Manage the creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments and expert functions.
  • Ensure communication with internal and external stakeholders regarding new and updated CCDSs.
  • Escalate deviation and compliance issues to labelling governance bodies as necessary.
  • Provide regulatory expertise to regulatory programs and projects, as well as to clients.
  • General guidance and consultancy of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
  • Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences.
Requirements
  • Experience in labelling documentation and informative texts for innovator drugs on a global level.
  • Ensuring that regulatory affairs, development consulting, and scientific affairs programs and projects are delivered to high standards.
  • Planning and expediting approval projects using internal or client-based software tools, including databases and document management systems.
What We Offer

At Montezuma Winery Llc, we offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, we encourage you to apply.