As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.
REQUIREMENTS:
Clear prioritization in accordance to business needs (governance boards)
Develop regulatory strategies aimed at achieving marketing authorization, regulatory compliant product labeling, and change notifications
Independently prepare and execute regulatory assessments of change requests
Independently establish, compile and submit documents in accordance with regulatory requirements aimed at achieving or maintaining marketing authorization
issue release statements for limited and for legal releases to Phadia AB
Active lead and expert in product registration projects on defined global markets
Communicate with internal and external partners as well as authorities including troubleshooting and removing barriers to execution
Participate in the vigilance process; monitor, assess and communicate regulatory requirements, regulations and guidelines in your area of expertise / global markets
Establish work procedures, instructions and templates within your area of expertise
Develop effective regulatory workflows and identify critical pathways with stakeholders and authorities
Contribute to improved routines and processes for the Global Regulatory Affairs team
Plan, lead, distribute and track activities within your regulatory specialist box
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Fluent in English, both spoken and written is a must
University degree in natural, pharmaceutical or technical science; 5+ years of experience within the regulated pharmaceutical, life science, MD or IVD industries and knowledge of relevant standards (e.g. ISO 13485, ISO 23640, ISO 14971, ISO 18113, ISO 15223)
6+ years of profound regulatory experience working with authorities worldwide and a thorough understanding of international regulations
Strong leadership, including meeting management, presentation skills and coaching
Results driven and team-oriented with the ability to influence outcomes as necessary
Excellent organizational and time management skills required to manage multiple ongoing business activities simultaneously
Excellent communication skills. Ability to communicate orally, in written documents, and in formal presentations is required
Awareness of and sensitivity to cultural diversities
Practical AI literacy, including the ability to use AI-enabled tools responsibly to improve efficiency, support analysis, and enhance the quality of deliverables.