The Role:The Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. To operate as...
Responsible for preparation of local product documents and their associated Local Language documents for their assigned markets, updating the labelling documents on a timely basis according to internal SOPs and external regulatory requirements. Also, act as a Subject Matter Expert on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence.
- Interaction with other cross functional roles in the delivery and management of labelling text through the appropriate processes and systems.
- Communicate, plan, prioritize and deliver labelling 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 labelling expertise.
- Utilisation of analytical skills to review and develop appropriate content for local labelling documents, based on core content, also recording the decisions made.
- Working within a framework of internal SOPs and working practices, and external regulatory requirements.
- 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.
- 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.
- Life Sciences Degree qualified.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.