Key Responsibilities:
This position provides regulatory labelling leadership, governance and expertise to company products such that the product information texts of existing and new products are successfully developed and maintained globally.
The role is responsible for management of the labelling process including development, creation, review approval global documentation (target label CCDS Core Patient Information) as well as territorial labelling documentation based on clinical non-clinical dossier support regulatory filings submission international agencies
Lets Labelling Strategy in partnership with Global Regulatory line overall strategy providing expert advice (labelling regulations internal processes impact analysis competitor profiles)
* Cover TPL CCDS USPI
Group managed EU SmPCs Centralized Mutual Recognition Decentralized Procedures abbreviated PIs thereof Establish close partnerships leads project leads functional teams ensure effective strategic proactive development Interfaces directly senior leaders business strategy labelling content Works closely aligned Regulatory Strategist stakeholder teams lead all aspects defined portfolio Lead updates critically evaluate data principles statements Clinical relevance acceptance across portfolio Chairs Product Labeling Team ensuring appropriate membership addressing need ad hoc members supportive functions necessary Working Global Medical Clinical Services Safety Surveillance Risk Management Safety contact verify agreed respective disciplines Where agreement cannot reached escalate issue Global Labelling Committee endorsement recommendations Negotiates resolution complex regulatory scientific issues manages projects simultaneously sound judgement solving problems Internally influences proposed guidelines regulations shape environment May active external facing activities representing industry groups workshops events Reviews promotional materials according code conduct counsels strategic review competitor existing documents Contribute leadership Labelling Organization drive governance GLC processes.