Compliance and Regulatory Expert
5 days ago
Job Description:
As a Regulatory Affairs Specialist, you will be responsible for planning, managing, and tracking regulatory CMC submissions and documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.
Your Key Responsibilities Will Include:
- Supporting activities at Thermo Fisher Scientific site(s) located in Norway for bead-based technology products and processes (part-time).
- Acting as a liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
- Collecting, consolidating, and ensuring accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
- Creating and maintaining up-to-date product technical documentation - Master Files.
- Reviewing and approving product labeling and marketing information to assure compliance with applicable requirements.
- Providing regulatory support and expertise to new product introduction project teams and different departments.
- Participating in change control activities by evaluating the impact of manufacturing changes on technical documentation and submitting updates to competent authorities.
- Developing regulatory affairs internal policies and procedures and providing training as needed.
- Avoiding inappropriate handling of confidential information.
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