
Regulatory Affairs Expert
7 hours ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at TN Norway.
Job Description:
The successful candidate will be responsible for planning, managing, and tracking regulatory CMC submissions and regulatory documentation. This includes 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 site(s) located in Norway for the bead-based technology products and processes (part time).
- Serve as the 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 assure 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 training as required.
- Appropriately handle confidential information.
Requirements:
- University degree in life sciences.
- Familiar with global Health Authority regulations/guidances, e.g., FDA regulations, ICH, and EMA guidelines/directives. Understanding of QMS standards (ISO 9001, ISO 13485) 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 the ability to learn new systems quickly.
- Strong analytical and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
- Willingness to travel 2-10% of the time.
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