Principal Reg Affairs Specialist (Remote) Principal Reg Affairs Specialist | Thermo Fisher Scientific | Italy
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. 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 – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
On this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies, and projects. You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
The following skills are required to be successful in this position:
Preparation and assembly of global regulatory submissions Interacting with sponsors Review and assess clinical trial regulatory documents Review and assess scientific literature Manage project teams and preparation Participate in launch meetings, review meetings, and project team meetings Experience with bid defense meetings Education and Experience:
Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job around 8+ years.
Expert knowledge of the global clinical trials landscape.
Knowledge, Skills and Abilities:
Excellent command of the English language (written and oral) as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial/proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines Excellent analytical, investigative, and problem-solving skills 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.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Apply today!
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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