Remote Regulatory Affairs Senior Manager in San Carlos

Job is Expired

Location: California

Compensation: To Be Discussed

Staff Reviewed: Sun, Oct 31, 2021

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A biotechnology company is filling a position for a Remote Regulatory Affairs Senior Manager.

Individual must be able to fulfill the following responsibilities:

  • Prepare, review or QC routine IND and CTA
  • Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule
  • Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects

Must meet the following requirements for consideration:

  • Minimum BA/BS degree in related field required; advanced degree preferred (or relevant experience)
  • At least 5-8 years’ experience in regulatory affairs or a related function in drug/biologic
  • Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format

COMPLETE JOB DESCRIPTION

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