Regulatory Affairs Manager

hace 4 semanas

Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager 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 regulatory requirements and managing the labelling and regulatory submissions process.

Key Responsibilities
  • Labelling and Regulatory Submissions: 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.
  • CCDS/CCSI/RSI Management: Manage the creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments and expert functions.
  • Stakeholder Communication: Ensure communication to internal and external stakeholders regarding new and updated CCDSs.
  • Deviation and Compliance: Escalate deviation and compliance issues to labelling governance bodies as necessary.
  • Regulatory Expertise: Provide regulatory expertise to regulatory programs and projects, as well as to clients.
  • Project Planning and Expediting: Plan and expedite approval projects using internal or client-based software tools, including databases and document management systems.
  • General Guidance: Provide general guidance and consultancy to PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
  • Presentation and Training: Present seminars and lectures on behalf of Montezuma Winery Llc internally, for customers, and for professional audiences.
  • Regulatory Documentation: Create, revise, edit, and maintain regulatory documentation.
  • Client and Health Authority Interaction: Interact professionally with clients and Health Authorities.
  • Project Team Coordination: Coordinate project teams with internal and external staff and Regulatory Alliance Partners on a worldwide level.
  • Strategic Regulatory Issues: Participate in strategic regulatory issues, including the definition of suitable methods of resolution.
  • Business Development Support: Provide technical support to business development, focusing on Labeling activities and adjacent areas on EU and global levels.
Requirements
  • Language Skills: Fluent business English or English as a native language, preferably with skills in another EU language.
  • Education: A degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
  • Experience: Professional experience in regulatory affairs, with a strong track record in labeling activities for innovator drugs on a global level.
  • Knowledge: Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
  • Skills: Affinity for databases, labeling software tools, and project management software, with the ability to closely monitor and adhere to timelines.
  • Personal Qualities: A team player, communicative, conscientious, accurate, and responsible.
  • Technical Skills: Confident with MS Excel and MS Word, as well as databases and document management systems.
About Us

Montezuma Winery Llc is a dynamic company with a strong focus on innovation and customer satisfaction. We offer a diverse and challenging work environment, with opportunities for continuous development and growth.

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