Job Summary
A biotechnology company specializing in developing therapeutics for people with serious and life-threatening, rare, genetic diseases has a current position open for a Remote Clinical and Non Clinical Regulatory Senior Associate.
Must be able to:
- Support the development of the nonclinical / clinical regulatory strategy and plan.
- Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with the Global RA Lead (GRL) and/or RA Nonclinical/Clinical (RNC) Lead.
- Collaborate with Reg PM to create and align submission timelines,
Qualifications for this position include:
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 3- 4+ years experience with PhD; 5-6+ years with Masters or bachelor’s degrees
- Nonclinical / Clinical Regulatory Affairs and rare disease experience preferred
- Excellent communication skills