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Global Labelling Manager
Major tasks and responsibilities include:
Manages core labelling documents for assigned BCH products in order to present all relevant data (chemical, pharmaceutical, pharmacokinetic, pharmacodynamic, preclinical, medical, drug safety) in a comprehensible form, to enable countries to produce, based on these, their HCP information and their patient information leaflet.
Leads cross-functional expert teams for the assigned BCH products, which jointly discuss the latest results and potential signals relevant to the products and their impact on the core labelling documents.
Finalizes core labelling documents for governance approval by Global Safety Labelling and Committee (GSLC). Following decision by the GSLC, initiates and audits implementation of CCDS agreed changes into local labelling documents in all countries where the product is registered and ensures timely submission by affiliates (invoke escalation procedure where required).
Ensures availability of up to date labelling documents and related documents in Regulatory Information Management System (RIMS).
Works with country regulatory staff, ISY BIA Beijing and GSLC to track country labelling decisions and the implementation of labelling changes and reporting these to Marketing Authorization Agencies as required.
Coordinates and contributes to evaluation of local labelling deviations in order to monitor harmonization of Bayer world-wide product information. Initiates corrective measures where possible and analyses possible impact of deviations on the core labelling documents. Consistently and properly escalates noncompliance issues according to Governance processes.
Follows labelling database / system related processes, auditing procedures and reporting tools to support database data integrity.
Works with Group Head Labelling CH to develop and maintain BCH- related labelling QSD and provide regular labelling compliance reports in close alignment with RMSC CoM.
Supports training for new staff in labelling relevant processes and IT systems.
Supports RA staff in creation/coordination of new or existing labelling documentation
Qualifications, Experience and Skills
- University Degree in Pharmacy, Regulatory Affairs, or Life Sciences
- 3 to 5 years of experience in a role within the pharmaceutical industry (Regulatory Affairs)
- Demonstrated understanding of regulatory labelling procedures, from creation to market implementation.
- Understanding drug development process and evidence of working with EU and/or US Regulatory Agencies.
- Ability to work as part of a team, ability to lead cross- functional teams.
- Ability to communicate effectively in English verbally and in writing.
- Customer orientation.
- Ability to work focused and target oriented in a complex scientific/ technical environment and to work on multiple projects in parallel. Capability to organize and direct diverse activities in a changing environment, often under time pressure. Ability to absorb large amounts of information efficiently, give sound judgements and act professionally to manage difficult situations effectively.
- Networking and influencing skills.
- Proficiency in MS Office: Word, Excel, PowerPoint.
- Knowledge of database concepts.
Are you up for the challenge? If so, please apply below.
United Kingdom : Berkshire : Reading