Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
Senior Reg Affairs Specialist - Lifecycle Management (FSP)
Job Purpose
Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with client's SOPs and working practices.
Mentors/coaches/trains other team members and reviews work to ensure right first-time submissions.
Key responsibilities
- 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 initiatives
Education Requirements
- Minimum level: Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment
- Preferred level: Bachelor degree or higher in biological or healthcare science
Job Related Experience (minimum Requirements)
- General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- General knowledge of Regulatory Affairs responsibilities for Lifecycle management
- Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Other Job-Related Skills
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Ability to work in a matrix environment, ensure delivery of objectives across cross-functional teams
What we offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
