Thermo fisher scientific
Regulatory Affairs Manager
Overview
As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
About Thermo fisher scientific
Thermo Fisher Scientific is a world leader in serving science, offering innovative solutions and services in regulatory affairs and clinical research.
Requirements & Eligibility
- Bachelor’s degree or equivalent relevant formal academic/vocational qualification.
- Typically 9+ years of relevant experience providing the knowledge, skills, and abilities required to perform the role.
- An equivalent combination of appropriate education, training, and directly related experience may be considered.
- Excellent written and verbal English communication skills, as well as local-language capability where applicable.
Key Responsibilities
- Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy.
- Translate the agreed indication-level strategy into an actionable trial-level regulatory strategy and execution plan.
- Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity.
- Drive the cross-functional clinical trial team to execute the agreed regulatory strategy and achieve study and program objectives.
- Lead the development and execution of global regulatory strategies and preparation of submissions to Regulatory Authorities and Ethics Committees.
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