Regulatory Affairs Specialist Ii

4 weeks ago

Basingstoke, United Kingdom Thermo Fisher Scientific Full time

**The job**:
You will be a member of the MBD Regulatory Affairs Team

and working as part of a combined team of Regulatory Affairs Professionals both site based and remote based colleagues.

**What will you do?**
- Facilitate timely licences for both pre-market approval and post market licence renewals in the Rest of the World International market place through technical data compilation submissions.
- Working within Market Access processes and systems to ensure accuracy of project information and requirements i.e. product listings & in country regulatory requirements necessary for satisfactory product registrations and renewals.
- Working with key collaborators (regional RA’s, Commercial teams, etc) to lead the timely completion of projects and provide updates on a biweekly basis in regularly scheduled meetings.
- Lead the successful implementation plan for submissions for pre market and post market licence approvals to meet the MBD annual prioritised plan.
- Compiling data from various sources and working with other departments and legal entities to generate data.
- Data compilation relating to In Vitro Diagnostic products for placement in ROW comprising technical information extracted from STED files which satisfy the in country RA regional requirements.
- To lead and facilitate change notification activities in various countries as instructed by business needs.
- To continuously stay abreast of regulatory knowledge making sure to understand regulations in various regions and their impact on current and future business activities.
- Leading compliance activities in ROW countries to ensure continued business and compliance with local regulations using the latest regulatory software packages.
- Lead Growth Projects such that products prioritised by the business can be steadily registered in the identified region.
- Work timely with Regional RA and Product RA to answer Competent Authority Questions with the identification of solutions to overcome the technical challenges should they present.
- Review documentation and obtain authentication from country embassies, UK FCO, etc as instructed to by local regulatory requirements.
- Training of new staff in MA processes to ensure they are competent and capable of leading registration projects this includes product training, systems, in country regional requirements & introductions to in company colleagues and co workers.
- Embody the company ethos and be an Ambassador for MBD Regulatory Affairs

**Who are we looking for?**
- Degree in Medical/Pharmaceutical Regulatory Affairs or related bioscience field including Microbiology and Chemistry preferred.
- Excellent IT skills
- Excellent attention to detail
- Ability to plan multiple tasks and effectively prioritize activities
- Effective communicator with management, peers and internal customers
- Capability to drive assignments to completion
- Good planning and organizational abilities
- Pro-active with proven ability to work under own initiative, and strong team player
- Perform duties in accordance with established company procedures and policies; perform other duties as assigned.

With Thermo Fisher Scientic, it’s not just a career. It’s a chance to realise your best - professionally and personally.

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