APAC Regional Labelling Manager
An internationally renowned pharmaceutical organisation is seeking to hire an APAC Regional Labelling Manager for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
- 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.
- 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. Champion and/or participate in continuous improvement efforts related to business practices and tools utilized within role.
- For deliverables in scope, support responses to inquiries from client colleagues in response to inspection activities and regulatory agency questions.
Skills and Requirements:
- English is prerequisite and other Asian languages such as Japanese, Korean, Thai, Malaysian would be highly preferred.
- 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
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Tom Tan at +86 21 51694101 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.
Proclinical Staffing is an equal opportunity employer.
Our client is a biopharmaceutical company focused on improving patients' lives in the therapeutic areas of hematology and oncology