Regulatory Submission Analyst - Regulatory Publishing, EMEA
Our client is a bold, global pharmaceutical company that is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Publishes submissions within the EMEA (Europe, Middle East and Africa) Region in line with current national and regional requirements for eCTD, NeeS and Paper applications.
Responsible for ensuring all published submissions are archived in accordance with internal global and regional SOPs.
Provides guidance (and where necessary training) to EAME Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities.
KEY DUTIES AND RESPONSIBILITIES:
* With limited supervision, publish regulatory submissions for the EMEA region in eCTD, NeeS and/or paper formats (dependant on local requirements).
* Provide support and guidance to the Regulatory Assistant responsible for despatching the published submissions ensuring that the correct submissions and documentation are sent to the correct destination.
* Recommend improvements and continue to develop regional processes and documentation in support of the EMEA publishing, despatch and archiving process.
* Contribute towards global processes and documentation to ensure that they incorporate EMEA regional requirements.
* Establish relationships with 'in-country' teams and global regulatory teams to ensure that the publishing team has a clear understanding of local submission requirements.
Education and Experience
* Good knowledge of European pharmaceutical regulations and guidelines
* Experience in publishing CP, MRP and DCP submissions, including eCTD, NeeS, and paper formats
* Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
* Knowledge/experience in publishing submissions for emerging markets (Middle East, Non EU Europe etc)
Essential Skills and Abilities
* Excellent written , verbal and interpersonal skills
* Excellent knowledge of submission guidance documents and regulations. Ability to independently review and adopt new/changing regulatory guidance into existing processes
* Strong understanding of the registration and maintenance process
* Ability to identify compliance risks and escalate when necessary
* Computer literate with working knowledge of Adobe Acrobat, Microsoft Word, ISI Toolbox, Documentum/First Doc and Liquent's Insight Publisher necessary to perform specific job functions
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