
Global Regulatory Solutions Manager
7 hours ago
We are seeking a skilled Regulatory Affairs Professional to join our team at TN Norway.
About the Position:
This is an exciting opportunity to work in a dynamic global organization and collaborate with expert professionals. As a member of the Regulatory Affairs Team, you will play a critical role in planning, managing, and tracking regulatory CMC submissions and regulatory documentation.
Your 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.
About Our Company:
TN Norway is a rapidly growing international company with an encouraging working culture and outstanding development possibilities to increase your potential.
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