Regulatory Affairs Manager for Labeling and Submissions

hace 4 días

Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery Llc. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for labeling and submissions.

Key Responsibilities

  • Participate in the preparation and revision of labeling documents for healthcare professionals and patients, including SmPC, PIL, and labeling, 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.
  • Offer guidance and consultancy to PharmaLex staff and customers on Regulatory Submissions & Labelling activities.
  • Present seminars and lectures on behalf of Montezuma Winery Llc internally, for customers, and for professional audiences.
  • Coordinate project teams with internal and external staff and Regulatory Alliance Partners on a worldwide level.
  • Participate in strategic regulatory issues, including the definition of suitable methods of resolution.
  • Provide technical support to business development, focusing on Labeling activities and adjacent areas on EU and global levels.

Requirements

  • Fluent business English or English as a native language, with skills in another EU language.
  • Completed degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
  • Professional experience in regulatory affairs with a strong track record in labeling activities for innovator drugs on a global level.
  • Experience in handling marketing authorizations and their lifecycle management.
  • Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
  • Affinity for databases, labeling software tools, and project management software, with the ability to closely monitor and adhere to timelines.
  • Team player with excellent communication, conscientious, accurate, and responsible skills.
  • Confident with MS Excel and MS Word, as well as databases and document management systems.

What We Offer

  • Diverse and challenging job opportunities.
  • Open and appreciative corporate culture.
  • Flexible working hours based on trust.
  • Possibility to work reduced number of hours.
  • Possibility to work from home.
  • Continuous development opportunities through knowledge and experience, as well as training.

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