Senior Regulatory Affairs Consultant

6 days ago

Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

We are looking for a Senior Regulatory Affairs Consultant to become a vital part of our Biosciences Division Regulatory Affairs Team. In this role, you will be responsible for the strategic planning, management, and oversight of regulatory CMC submissions and essential regulatory documentation, including Drug Master Files for various materials utilized in the production of cell and gene therapies.

Key Responsibilities:

  • Support activities at Thermo Fisher Scientific sites for bead-based technology products and processes.
  • Act as a liaison between research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and Intellectual Property Legal.
  • Gather, consolidate, and verify the accuracy of documentation required for regulatory support in target markets.
  • Create and maintain comprehensive product technical documentation, including Master Files.
  • Review and approve product labeling and marketing materials to ensure compliance with applicable regulations.
  • Provide regulatory support and expertise to new product introduction project teams and various departments.
  • Engage in change control activities by assessing the impact of manufacturing changes on technical documentation and submitting updates to the relevant authorities.
  • Develop internal policies and procedures for regulatory affairs and conduct training sessions as necessary.
  • Handle confidential information with the utmost care.

Qualifications and Experience:

  • A university degree in life sciences.
  • Familiarity with global Health Authority regulations and guidelines, such as FDA regulations, ICH, and EMA directives, along with an understanding of QMS standards (ISO 9001, ISO, and GMP requirements).
  • Over 3 years of experience in regulatory affairs or within the pharmaceutical or medical device manufacturing sector.
  • Ability to plan, prioritize, and coordinate work processes independently with minimal supervision.
  • Proficient in computer programs and systems (e.g., MS Office) with a demonstrated ability to learn new systems quickly.
  • Strong analytical and problem-solving skills, with the capability to work effectively with cross-functional teams.
  • Willingness to travel occasionally.

What We Offer:

  • An innovative environment within a rapidly growing international company that fosters a supportive working culture and offers exceptional development opportunities.
  • The chance to work in a dynamic global organization and collaborate with expert professionals.

Compensation and Benefits:

The estimated salary range for this position is €31,000 to €42,000.

At Thermo Fisher Scientific, our diverse team of over 100,000 extraordinary individuals contributes to our mission—enabling our customers to make the world healthier, cleaner, and safer.

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