The role of Regulatory Publishing Consultant is a new job position for an innovative technology-driven multi-speciality healthcare company based at their Buckinghamshire site. This multinational biopharmaceutical organisation who specialise in research and development, and work to develop an unparalleled level of insight into patients’ needs.
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.
1. Publishing Regulatory Submissions 70%
- 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.
2. Report Level Publishing 10%
- With limited supervision, publishes complex reports to support regulatory submissions for the EMEA region (DSURs, IMPDs, RMPs and Scientific Advice Briefing Packages etc)
- Recommend improvements, develops processes and deliver's training relating to report level publishing.
3. Archiving 5%
- Update the Global Regulatory Information Management and e-archive systems to ensure all submissions are archived in accordance with internal SOPs.
4. Regulatory Advice & Intelligence 15%
- Interpret regional/local requirements and provide advice and guidance to Regulatory Affairs to ensure submissions meet relevant requirements.
- Provide training to EMEA Regulatory Affairs as and when necessary on relevant software, processes and submission format related topics.
- Participate as an active team member within the Global Publishing Group and provide updates from the EMEA region.
- Prepares and delivers presentations as and when required.
Education and Experience
- Graduate (preferably in a Life Science), and previous experience in a Regulatory Publishing setting.
- 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.
- Ability to multi-task, prioritize, and manage multiple projects and deadlines
- Exercise independent judgment
- Sense of personal responsibility and accountability
- Ability to travel
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 Elise Lambeth on +44 207 4400 633 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.