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Regulatory Affairs Specialist III

2 weeks ago

Oslo, Oslo County, Norway TN Norway Full time

We are seeking a highly skilled Regulatory Affairs Specialist to join our Biosciences Division Regulatory Affairs Team. The ideal candidate will have a strong background in life sciences and experience in managing regulatory CMC submissions and documentation.

Key Responsibilities:

  • 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 applicable requirements.

Requirements for Qualification / Education / Experience:

  • University degree in life sciences.
  • Familiarity 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.

We Offer:

  • An innovative environment with an encouraging working culture and outstanding development possibilities.
  • A dynamic global organization with expert professionals.