Regulatory Affairs Associate, EAP - London

Only for registered members London, United Kingdom

1 week ago

Default job background
+Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. We are looking for a Regulatory Affairs Associate to deliver strategic and operational regulatory support and expertise to the Regulatory team and clients.+

Qualifications

+
  • Bachelor's degree in a healthcare/science-related subject.
  • Previous experience in a regulatory affairs, or relevant related role within the pharmaceutical medicine environment, EAP would be preferable.

Responsibilities

+
  • Manages day-to-day regulatory affairs activities to ensure adherence to all regulatory obligations and responses,
    including monitoring and actioning the Regulatory Inbox, portal request regulatory review process and required translations,
    SUPPORTS THE DEVELOPMENT AND ONGOING MAINTENANCE OF REGULATORY STRATEGY REPORTS TRACKERS AND LABEL TEXT PLANS AS ASSIGNED BY THE REGULATORY LEAD,
    CREATES NEW ENTRIES AND MAINTAINS TRACKERS THAT CAPTURE REGULATORY ACTIVITIES RELATED TO THE SET-UP MAINTENANCE AND CLOSE-OUT OF EAPS AS ASSIGNED BY THE REGULATORY LEAD,PARTICIPATES IN INTERNAL AND EXTERNAL PROGRAM-SPECIFIC CALLS AS ASSIGNED BY THE REGULATORY LEAD
    ,AND DOCUMENTS RELEVANT REGULATORY UPDATES DELIVERABLE FOR ESCALATION FOLLOW-UP,SUPPORTS THE DEVELOPMENT
    Maintenance of database containing global regulations awareness updates actively sharing knowledge with wider team ensures all training departmental policies SOPs completed maintained.
    ,

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