Job Summary
A staffing company is filling a position for a Telecommute Regulatory Strategist V.
Candidates will be responsible for the following:
- Assuring product compliance through timely and accurate maintenance of CMC submission documentation
- Leveraging both technical & regulatory knowledge, to mitigate risks
- Executing regulatory policies and operational processes
Applicants must meet the following qualifications:
- Technical discipline with 8 years of experience in the pharmaceutical industry
- 3 years pharmaceutical regulatory experience
- Bachelor's degree or equivalent/graduate degree
- Minimum of 2 years of hands-on CMC authoring experience
- Experience operating within GMP, GLP, or GCP related SOPs
- 3+ years management & supervisory experience with technical projects &/or staff