Administration Co-Ordinator, Regulatory Affairs

Administration Co-Ordinator, Regulatory Affairs
As Administration Co-Ordinator, Regulatory Affairs you will be based at our Central Cambridge site, you will be responsible for supporting the Executive Director and two Senior Directors within the Regulatory Affairs Management (RAM) group of ORSSE and be part of the team providing administrative and project coordination support for regulatory teams located across R&D sites in Cambridge and Macclesfield, Gaithersburg MD in the US, Warsaw in Poland and Bangalore in India. The Administration Co-Ordinator, Regulatory Affairs role will involve executive and senior director level contact globally in a dynamic and complex business environment, working with sensitive and confidential information.
Some of the main responsibilities of the Administration Co-Ordinator Regulatory Affairs role:
* On behalf of the Executive Director and the two Senior Directors, coordinate and liaise with the administrative support of other senior leaders, maintaining high professional standards while resolving conflicting needs.
* Triage email management via agreeing on what can be sent/responded, when and to whom.
* RAMs Recruitment and On-boarding support: works with HR and Talent Acquisition team to support interview planning and scheduling as needed, provide interview packs, order equipment (including Coupa), update Capit system accordingly.
* RAMs Off-boarding: supports RAMs off-boarding activities.
* Management of staff data and capacity management systems, provide regular updates and status reports as required.
* European Medicines Agency (EMA) point of contact cross Therapy Area-TA for regulatory fees. Management and monitoring of Purchase Orders and invoices within appropriate Finance systems.
* Administer and be an expert user of essential IS/IT administrative systems to increase efficiency in day-to-day work, including meeting technology, Miro Board, SharePoint Online, MS Teams, Zoom, Coupa, etc. Provide general admin support for the group supporting the line managers with timecards, distribution lists, organograms, trackers as needed, with an eye for detail and consistency across the different systems.
Some of the required skills & capabilities required for the Administration Co-Ordinator Regulatory Affairs role:
* Ability to exercise considerable discretion, judgment, tact, and diplomacy
* Ability to resolve issues and challenges relating to administrative requests independently and pro-actively
* Excellent interpersonal and communication skills as demonstrated by the ability to work effectively with others at all levels of the organization and externally
* Some project management skills to effectively manage events/small projects
* Passion for the digital space and curious about how to solve challenges leveraging digital technologies
* Education up to 'A' level standard is required, bachelor's degree strongly preferred
* 5-+ years of experience in a senior administrative role supporting complex projects.
* Experience providing high quality, professional support service, working proactively and independently without day-to-day direction.
* Demonstrate flexibility and adaptability to meet changing business demands.
The Administration Co-Ordinator, Regulatory Affairs role is an exciting position that will be filled quickly, please get in touch with your CV as soon as possible.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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