A growing pharmaceutical company in Boston is seeking a Regulatory Affairs Manager on a contract basis.
The company is based in South Boston and focuses on the treatment of cancers including multiple myeloma as well as neurodegenerative, inflammatory, metabolic, genetic and infectious parasitic diseases.
- Manage preparation/review of CMC and clinical submissions
- Review technical documentation to ensure regulatory compliance
- Assist with research/implementation of effective regulatory strategies
- Ensure compliance with existing regulatory applications
- Bachelor's degree in scientific field
- 5+ years regulatory experience
- Experience in oncology environment
- Strong familiarity with FDA and EMA clinical/CMC guidelines
- Excellent communication skills, particularly written