Regulatory Affairs Specialist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

We are currently seeking a Regulatory Affairs (RA) Specialist to join Biosciences Division Regulatory Affairs Team. As a member of the RA team, you will be planning, managing, and tracking of 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.

REQUIREMENTS FOR QUALIFICATION / EDUCATION / EXPERIENCE:

• University degree in life sciences.
• Familiar with global Health Authority regulations/guidances eg. FDA regulations, ICH and EMA guidelines/directives. Understanding of QMS standards (e.g. 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.
• Abilities to plan, prioritize and coordinate working process independently and with minimal direction.
• Proficiency with computer programs/systems (MS office, etc.) with demonstration. Ability to learn new systems quickly.
• Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
• Willingness to travel 2-10% of time.

• Support of activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time).
• Serving as the 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 the applicable requirements.
• Providing regulatory support and expertise to new product introduction project teams and different departments.
• Participating in change control activities by evaluating impact of manufacturing changes on technical documentation and submitting updates to the competent authorities.
• Developing regulatory affairs internal policies and procedures and providing trainings as and when required.
• Appropriately handling confidential information.