Description
We are seeking a Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM to join our team.
As a Sr Regulatory CMC Consultant, you will be responsible for providing regulatory support for small molecule and Veeva RIM projects.
Responsibilities
- Good knowledge of North America regulatory affairs framework
- Understanding of requirements and processes to maintain a product on market, report, and surveillance
- Understanding of drug development and related concepts
- Ability to assess and understand regulatory guidelines
- Strong written and verbal communication skills
- Ability to work effectively within a team environment
- Ability to plan, prioritize and contribute to work and projects in systematic and efficient manner
Requirements
- Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
- Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience
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