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Regulatory Affairs Professional
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our Biosciences Division Regulatory Affairs Team at Thermo Fisher Scientific. As a key member of the team, you will be responsible for planning, managing, and tracking regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.
Key Responsibilities- Support activities at Thermo Fisher Scientific sites located in Norway for bead-based technology products and processes (part-time).
- Serve as a liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
- Collect, consolidate, and ensure accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
- Create and maintain up-to-date product technical documentation - Master Files.
- Review and approve product labeling and marketing information to ensure compliance with applicable requirements.
- Provide regulatory support and expertise to new product introduction project teams and different departments.
- Participate in change control activities by evaluating the impact of manufacturing changes on technical documentation and submitting updates to competent authorities.
- Develop regulatory affairs internal policies and procedures and provide trainings as required.
- Handle confidential information appropriately.
- University degree in life sciences.
- Familiarity with global Health Authority regulations/guidances (e.g. FDA regulations, ICH, and EMA guidelines/directives) and understanding of QMS standards (ISO 9001, ISO, and GMP requirements).
- Experience in the field of regulatory affairs and/or in the pharmaceutical or medical device manufacturing company for over 3 years.
- Ability to plan, prioritize, and coordinate working processes independently and with minimal direction.
- Proficiency with computer programs/systems (MS Office, etc.) with demonstration and ability to learn new systems quickly.
- Strong analytical skills and problem-solving skills, with the ability to coordinate and work effectively with cross-functional teams.
- Willingness to travel 2-10% of the time.
- An innovative environment in a rapidly growing international company with an encouraging working culture and outstanding development possibilities to increase your potential.
- An opportunity to work in a dynamic global organization and collaborate with expert professionals.
The salary range estimated for this position based in Lithuania is €31,–€42,.
