Regulatory Affairs Specialist Ii - Basingstoke, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Basingstoke, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 premarket 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
Proactive 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.