Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)
Parexel(13 days ago)
About this role
Parexel is seeking an experienced CMC Regulatory Affairs Senior or Consultant to support the development and lifecycle management of small-molecule and biologic products. The role involves strategic regulatory planning, documentation, cross-functional collaboration, and process improvement, primarily across the US, EU, and Canada.
Required Skills
- Regulatory Affairs
- CMC
- GMP
- Documentation
- Regulatory Strategy
- FDA
- EMA
- Health Canada
- Process Optimization
- Regulatory Systems
Qualifications
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology
- RAC certification
About Parexel
parexel.comFor over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.
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