To be accountable for operational management of regional and/or national regulatory dossiers to designated Health Authorities. This role sits within a team working to tight, business-critical deadlines within a highly regulated environment. Primary focus is on allocated region/ countries, with additional responsibility to support other locations through utilization of global tools.
- Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
- Delivering project specific company electronic and paper regulatory submissions. Including co-ordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
- Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
- Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
- Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
- Degree in any Life Sciences
- Demonstrated coordination of activities in a highly regulated environment
- Relevant experience in electronic submissions within the Pharmaceutical Industry
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.