Remote CMC Senior Regulatory Affairs Specialist in Seattle

Job ID: Available for Members

Location: Washington

Compensation: Salary

Staff Reviewed: Tue, Sep 24, 2019

Job Category: Consulting, Healthcare

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Additional Information: Benefits Available

Job Summary

A biotech consulting firm has a current position open for a Remote CMC Senior Regulatory Affairs Specialist in Seattle.

Individual must be able to fulfill the following responsibilities:

  • Identify risks and diplomatically propose plans to mitigate risks
  • Assist in negotiations with regulatory agencies
  • Build positive relationships with clients

Applicants must meet the following qualifications:

  • 25% travel
  • A Bachelor's degree with 10+ years of biologics, biosimilar or combination product industry experience
  • At minimum of 5 years of experience in Regulatory Affairs is required
  • Previous experience developing CMC regulatory strategy
  • Previous experience managing directly/indirectly other people to manage in a matrix team environment is required