The Labelling Manager is responsible for executing the content management of l local product documents (LPDs) regardless of registration procedure including USPIs and Centralised Procedure SmPCs for their assigned products across multiple countries/regions.
This role will oversee content across all labels for their assigned products in their assigned regions and drive consistency of content and messaging wherever possible.
PRINCIPAL RESPONSIBILITIES include:
Utilise regulatory expertise to review, develop and deliver core labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
Engaged in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary.
Ensure that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
Communicate, plan, prioritise and deliver submission documents according to company targets and submission requirements; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained.
Ensure appropriate tracking of labelling projects via defined procedures and optimal use of systems.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Life sciences, pharmacy graduate or equivalent.
Hands on registration experience associated with development, maintenance and commercialisation activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs.
Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
Demonstrated ability to interpret and apply regional/local regulatory guidance around labelling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
PERSONAL SKILLS & ATTRIBUTES:
Excellent written and verbal communication skills essential.
Proven strength in logical, analytical and writing ability essential.
Demonstrated project management, attention to detail and problem solving skills required.
BENEFITS OF THE ROLE:
This Company that has been consistently recognised as one of the nation''s best employers offers state of the art R&D facilities and workplaces that have been designed to meet their employees'' needs with flexible hours, childcare centres, health and fitness facilities and sports and recreational opportunities. You can be assured of a competitive remuneration together with comprehensive and customised benefits and competitive, performance-based compensation.
Fforde is acting as a recruitment agency/business.
Labelling, regulatory, contract, Surrey, life sciences, pharmaceutical.
Posted: 14/08/2012 | NPJ Ref: 85051