Senior Reg Affairs Spec - Lifecycle Management (FSP)

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department – FSP team. The role will have a focus on Lifecycle Management activities. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting as well as deep dive into one of our key clients’ environment.

• Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with client’s SOPs and working practices
• May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)
• May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
• May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
• May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
• May be required to provide guidance to project teams and client groups on client’s submission related processes and content and format requirements for key markets
• May be required to lead or participate to process improvement initiative