Regulatory Affairs Manager

Há 20 horas


Lisboa, Lisboa, Portugal PharmaLex Tempo inteiro

About the Role

PharmaLex is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our labelling and regulatory submissions group, you will be responsible for managing the creation and maintenance of regulatory documentation, including SmPCs, PILs, and labelling.

Key Responsibilities

  • Participate in the preparation and revision of informative texts for healthcare professionals and patients in EU and non-EU markets.
  • Manage the creation and maintenance of CCDS/CCSI/RSI documents in collaboration with relevant departments.
  • Ensure effective 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.
  • General guidance of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.

Requirements

  • Fluent business English or English as a mother tongue.
  • Professional experience in regulatory affairs with a track record in labeling activities for innovator drugs on a global level.
  • 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.
  • Team player, communicative, conscientious, accurate, and responsible.

About Us

PharmaLex is a leading provider of regulatory, scientific, and consulting services to the pharmaceutical and biotechnology industries. We offer a diverse and challenging job, open and appreciative corporate culture, flexible working hours, and opportunities for continuous development.



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