Description
One of Volts leading pharmaceutical clients are recruiting a Global Labelling lead for a 12 month contract.
Position Purpose
The Global Labelling Lead (GLL) has overall accountability for the initial creation and relevant updates to labelling documents for their assigned products globally. This includes guiding the Labelling Team to facilitate development of source labels (eg CDS.) The GLL reviews the downstream impact of source label updates on local product documents (LPDs) as well as ensures that any associated patient/technical leaflets are updated, regardless of registration procedure. This would include USPIs and Centralised Procedure SmPCs. The GLL ensures that any required updates on LPDs across the globe are properly assessed and proactively managed by the Hub Labelling Manager (HLM). The GLL must ensure these documents are produced in a timely manner according to internal SOPs and meeting external regulatory requirements. The GLL role serves as the primary point of contact for labelling teams and will provide day-to-day direction to Labelling Operations Specialists so that necessary source label documents and decision documentation can be prepared and managed appropriately throughout processes and systems. This role will keep up to date with labelling regulations and oversee product labelling requirements globally. Additionally the role will have oversight of content messaging across local labels for their assigned products and should support and drive consistency across regions wherever possible. This role will interface with the Labelling Operation Specialist and Hub Labelling Managers, WRS Strategist and Labelling Team members, PCO colleagues, MDL Authors, Global/Regional Medical TA Leads, and Submissions Specialists in the delivery and management of labelling text through appropriate processes and systems to assure the timely submission and ultimate approval of product labelling across the globe. This role will act as an Subject Matter Expert (SME) on regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence. Additionally this role will support the use and development of current and new tools, technologies and processes to support efficient global label development, submission and approval in respective countries.
This right candidate:
Education:
1. Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as PhD an advantage but not essential
Experience:
1. Significant '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 (at a global/multi-national pharmaceutical environment).
2. Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
3. Demonstrated ability to interpret and apply global and local regulatory guidance around labelling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages
4. Understanding of regulatory authority philosophy and expectations
5. Knowledge of global/regional regulatory guidelines and requirements important
6. Knowledge of Clinical Variations preferred