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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Thermo Fisher Scientific is a global leader in enabling our customers to make the world healthier, cleaner and safer.
Our Global Regulatory Affairs team is expanding, and we are looking for a Regulatory Affairs Lead to support clinical trial activities for one of our key clients.
The client is a global mid-sized biotech company focused on developing innovative treatments for patients with autoimmune diseases.
This role requires global experience; EU Clinical Trial Regulation experience is important.
The Regulatory Affairs Lead will act as the lead over several countries/projects, providing regulatory expertise and client interface to deliver strategic regulatory intelligence and guidance supporting product development from preclinical through registration and optimization.
They will prepare deliverables that meet local, regional and ICH regulatory and technical requirements, and act as liaison with internal and external clients to market these services.
Essential Functions: Provides senior review of regulatory documents and submissions to ensure high quality standards that meet local and regional requirements.
Acts as subject matter expert in regulatory strategy advice to internal and external clients on projects of moderate complexity, providing up-to-date legislation and guidance.
Participates in project management activities to support regulatory services and acts as liaison with clients for marketing these services.
Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, risk assessment, and achievement of project deliverables.
May provide input on performance reviews to management.
Ensures adherence to project budgets, timelines and scope of work.
Ensures compliance with relevant SOPs and regulatory procedures.
Contributes to business development activities, including project budgeting/forecasting.
Qualifications Education and Experience Bachelor's degree or equivalent with relevant formal academic/vocational qualification 8+ years of experience or equivalent combination of education, training and/or directly related experience Equivalency considered in some cases Knowledge, Skills and Abilities Excellent English communication skills; local language skills where applicable Great attention to detail and strong editing/proofreading abilities Strong interpersonal skills and ability to liaison across departments Solid computer skills (Microsoft Word, Excel, PowerPoint) and ability to learn new technologies Strong organizational and time management skills with ability to manage multiple projects Strong negotiation skills Ability to work independently and exercise judgment to meet sponsor regulatory needs and deliver compliant deliverables Solid understanding of integral/regional/national regulatory requirements for clinical trial authorization and lifecycle management; knowledge of ICH and EU Clinical Trial Regulation; CTA submissions experience preferred Experience with Global CTAs is advantageous Strong understanding of medical terminology, statistical concepts, and guidelines Analytical, investigative and problem-solving abilities Budgeting and forecasting knowledge Ability to perform Line Management responsibilities What we offer Competitive salary and extensive benefits package focused on employee health and well-being.
Flexible working culture and a collaborative, global environment with a local feel.
Our mission is to enable our customers to make the world healthier, cleaner and safer, and we value integrity, intensity, innovation and involvement.
Apply today!
Our jobs site: 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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