Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 Principal 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.

Principal Reg Affairs Specialist - Lifecycle Management (FSP)

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, pre-approval/investigational 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 practicesMay be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, 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 accountabilitiesMay 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 marketsMay be required to lead or participate to process improvement initiativesMay be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL.

Education Requirements

Minimum level: Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environmentPreferred level: Bachelor degree or higher in biological or healthcare science 

Job Related Experience

Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.Broad knowledge of Regulatory Affairs responsibilities from MAA to Lifecycle managementAbility 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 mannerExcellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management toolsAbility to lead in a matrix environment and ensure delivery of objectives across cross-functional teamsAbility to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.

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.

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