Central Regulatory Affairs Team Administrator
Central Regulatory Affairs Team Administrator
Reporting to; Director Central Regulatory Affairs
Tenure; Full-time, permanent
We are seeking a motivated and enthusiastic individual with excellent administrative and organisational skills to support the Central Regulatory Affairs team.
Primarily the CRA Team Administrator will support the Director of CRA and team members by performing administrative tasks relating to the functioning and smooth running of the team.
Whilst many tasks are routine, the CRA Team Administrator should have the ability to switch from proactive to re-active in order to manage activities against business priorities and enjoy working in a dynamic environment
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
To support the Director of CRA
- Organise meetings on behalf of the Director of CRA, ensuring meeting rooms are set up and prepared for attendees
- Look ahead in calendar to ensure that agendas are prepared for meetings, prepare and circulate meeting materials and take minutes/record actions as required
- Ensure calendar is well organised and maintained, working pro-actively with others to resolve diary and meeting room conflicts
- Prioritise schedules and activities based on changing needs
- Monitor inbox and progress actionable items
- Build PowerPoint slides, review slide decks for consistency and format
- Prepare and respect confidential information
- Support the compilation of budget informationTo support CRA Team Members
- Organise travel/accommodation booking
- Create purchase orders in E1, process invoices, process expenses on behalf of the team
- Organise couriers
- Organise annual memberships and renewals
- Co-ordinate translations with external service provider
- Maintain the CRA Genie intranet page to ensure content is well presented, up to date and relevant
- Co-ordinate all activities to be ready for new starters, desk space with facilities, processing of all IT forms, induction plan and introductory meetings and set-up of training curriculum
- Establish and maintain training curriculum for RA service providers
- Organise archiving requests and retrievals
- Ensure that the team have what they need to run effectively, including office supplies
- Organise and support team build events and Tribe initiatives from conception to delivery
- Establish and maintain Power of Attorneys (PoA), liaise closely with legal to ensure timely processing
- Organise the legalization and notarisation of certificates and documents necessary for any regulatory procedures
- Act as CESP administrator for Norgine regulatory colleagues, i.e. setting up user accounts as relevant.
- Back up for PA to VP
- Maintain team organograms, distribution lists and assigned SharePoint Sites
- Organise catering for meetings
SKILLS & KNOWLEDGE
- Good interpersonal skills, motivated to help others with the ability to work collaboratively within a team
- Keen to take initiative and be proactive when communicating with team members, ensuring consistency in messaging
- Able and confident to communicate with all levels
- Able to be authoritative through influencing
- Willing to adapt and able to work under pressure and to tight deadlines, following up with stakeholders as necessary
- Great prioritisation and organisational skills
- Excellent attention to detail, ability to assess information critically and suggest alternatives, where relevant. Good problem solving skills
- Sound English language grammar and writing skills
- Proficient in Microsoft Office- Word, Excel, Outlook, PowerPoint, SharePoint and knowledge of regulatory systems as well as inter/intranet.
- Creative with ideas and ways of working Qualifications
- Educated to 'A' level standard minimum
- Experience in a RA function, with high level knowledge of some regulatory processes and requirements preferable.Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit www.norgine.com
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.