HUB Labelling Manager

Job Role:

• Primarily responsible for preparation of local product documents (LPDs) and their associated Local Language documents (LLDs) for their assigned markets, updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
• Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence.
• Support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.

Primary Responsibilities:

• Interaction with other cross-functional roles in the delivery and management of labeling text through the appropriate processes and systems
• Communicate, plan, prioritize and deliver labeling 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.
• Development of subject matter expertise for assigned markets or products, and ongoing development of labeling expertise
• Utilisation of analytical skills to review and develop appropriate content for local labeling documents, based on core content, also recording the decisions made
• Working within a framework of internal SOPs and working practices, and external regulatory requirements
• Supporting the use of relevant tools and technologies within the course of the label development and translation process
• Utilisation of regulatory expertise to review, develop and deliver core/local 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.
• Engagement 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.

Role Responsibilities:

• Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
• Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation Qualifications (i.e., preferred education, experience, attributes)
• 1 year of pharmaceutical experience desired
• Experience of working within corporate systems and procedures
• Excellent project management skills, and ability to plan and prioritise, working within specific deadlines
• Written and verbal communications clear and effective, fluency in English essential

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.