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Regulatory Labelling Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
322503/11
IHRE AUFGABEN:
-Responsible for supporting the development of and managing the maintenance of Core Data Sheets (CDS) and associated product information documents
-Provide strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
-Take over the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities
-Provide support for other CDS-related activities and initiatives as required
-Support the implementation of CDS changes into the Local Product Labels (LPLs) and take part in tracking local label compliance and local label deviations
-Support the review process for product label changes (e.g. from health authorities)
-Provide competitive labelling comparisons as required for CDS preparation
-Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures
-Maintain an overview of relevant global regulatory labelling requirements
IHRE QUALIFIKATIONEN:
-B.Sc. in a life science subject or in a closely related discipline and solid experience/expertise in regulatory affairs (preferably labelling)
-Experience of developing or maintaining core data sheets for medicinal products
-Excellent team working skills with well-developed interpersonal skills
-An accomplished communicator with good written and verbal communication skills
-Ability to successfully plan and organise your own workload
-Committed to producing high quality outputs and demonstrate excellent attention to detail
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
322503/11
IHRE AUFGABEN:
-Responsible for supporting the development of and managing the maintenance of Core Data Sheets (CDS) and associated product information documents
-Provide strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
-Take over the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities
-Provide support for other CDS-related activities and initiatives as required
-Support the implementation of CDS changes into the Local Product Labels (LPLs) and take part in tracking local label compliance and local label deviations
-Support the review process for product label changes (e.g. from health authorities)
-Provide competitive labelling comparisons as required for CDS preparation
-Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures
-Maintain an overview of relevant global regulatory labelling requirements
IHRE QUALIFIKATIONEN:
-B.Sc. in a life science subject or in a closely related discipline and solid experience/expertise in regulatory affairs (preferably labelling)
-Experience of developing or maintaining core data sheets for medicinal products
-Excellent team working skills with well-developed interpersonal skills
-An accomplished communicator with good written and verbal communication skills
-Ability to successfully plan and organise your own workload
-Committed to producing high quality outputs and demonstrate excellent attention to detail
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges