Regulatory Affairs Consultant - UK/IE Affiliate
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Hobson Prior are currently working with a large pharmaceutical organisation who are looking for a Regulatory Affairs Consultant - UK/IE Affiliate to join them on a contract basis. This position will be accountable for providing technical and administrative support to the UK and Ireland Regulatory Affairs Department.
- Maintenance of existing and new Marketing Authorisations in the UK and Ireland registered via national, MRP, DCP and Centralised procedures in support of the organisation's UK and Ireland's commercial activities and strategy.
- Registration of new PLGB CAP conversions.
- Gaining familiarity with the organisation's UK and Ireland product ranges and keeping up to date with regulatory legislation and guidelines in the UK, Ireland and the EU.
- Provision of support to Global Regulatory Affairs in relation to regulatory applications.
- Ensuring appropriate communication with key stakeholders internally and externally, including with the Regulatory Authorities, negotiating where required to ensure a positive outcome for the organisation and providing monthly updates to the wider team.
- To ensure quality standards are consistently met and submissions are made according to the agreed deadline.
- An effective communicator both written and verbal.
- Computer literate, including Microsoft word, Adobe Acrobat and Microsoft Excel skills.
- Strong planning, time management and organisation skills.
- Educated to at least degree level in a scientific discipline.
- Knowledge of national, MRP and DCP & Centralised procedures in the UK and/or Ireland.
- A minimum of 8 years' experience within a regulatory affairs role within the pharmaceutical industry.
- Experience of preparing and submitting post-marketing regulatory applications to the MHRA and HPRA (i.e. variations, renewals, post-marketing commitment submissions, PSURs and other ad hoc activities as required)
- Experience of writing and updating comprehensible, clear, product information documents, including development of labelling and leaflet artworks.
- Keeping up to date with Regulatory intelligence and sharing accordingly.
- Contributing usefully to regulatory discussions.
- Experience of producing written regulatory communications with clarity, accuracy and rigor.
- Experience of working within electronic regulatory tracking databases and document management systems.
- Experience of working with eCTD and NeeS submission formats.
- Experience of working in a local affiliate regulatory affairs department.
- Experience of seeking Scientific Advice and liaising with the regulatory authorities over new products/new indications/line extensions.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.