Sr Associate Regulatory Affairs AFP

Location: Thousand Oaks, CA
Date Posted: 07-19-2018
Day to Day Responsibilities:
  • Ensure regulatory submissions are completed on time and meet Amgen’s corporate and local regulatory requirements, as applicable
  • Contribute to and execute the filing plan for assigned products and countries, as applicable
  • Develop and Review source text for country labeling
  • Disseminate relevant information to team(s), as appropriate
  • Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams and provide advice on local regulatory considerations in a timely manner.
  • Coordinate and QC translations of technical documentation (CMC, clinical and legal) for local regulatory submission. 
  • Ideal candidate- Must be Bi-lingual English/Spanish- both written and verbal. BS or MS in Health Sciences (Biotechnology, Chemistry, Biology, Biochemistry, Pharmacy or similar).
  • Manager would also look at recent grad or someone completing MS in regularly with no industry experience if bi-lingual and right type or person.
  • Cross functional role-will be collaborating , QC labeling documentation, complaining and submitting submissions and compiling data and archiving in a highly regulated documents.

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