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