Remote Regulatory Affairs Specialist

Job Summary

A healthcare company is filling a position for a Remote Regulatory Affairs Specialist.

Candidates will be responsible for the following:

• Collaborating with the medical writing team in the preparation and QC of the above documents
• Liaising with internal and external clients in tracking status
• Maintaining SOPs and updating requirements based on current regulatory guidelines

Qualifications Include:

• Bachelor’s degree required in a life science field or equivalent
• 1-3 years prior relevant experience in a CRO/pharmaceutical environment
• Good English language skills both written and oral
• Good attention to detail and quality as well as editorial and proofreading skills
• Familiarity with principles of drug safety, US guidelines, drug development, biostatistics, pharmacology
• Good computer skills including Microsoft Word, Excel, Power Point and ability to learn new technologies