Associate Director CMC Regulatory Affairs
Virtual Vocations Inc, New York, NY, United States
A company is looking for an Associate Director, CMC Regulatory Affairs to support global regulatory CMC activities for viral vector-based programs in a remote contract position.
Key Responsibilities
Support development and execution of CMC regulatory strategies for gene therapy programs Author and review CMC sections of regulatory submissions including INDs and CTAs Collaborate with cross-functional teams to assess manufacturing changes and comparability approaches
Qualifications
MS or PhD in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or a related discipline 7-10 years of experience in CMC regulatory affairs supporting biologics or gene therapy programs Direct experience contributing to CMC sections of IND or CTA submissions Working knowledge of viral vector platforms such as AAV or lentiviral systems
Support development and execution of CMC regulatory strategies for gene therapy programs Author and review CMC sections of regulatory submissions including INDs and CTAs Collaborate with cross-functional teams to assess manufacturing changes and comparability approaches
Qualifications
MS or PhD in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or a related discipline 7-10 years of experience in CMC regulatory affairs supporting biologics or gene therapy programs Direct experience contributing to CMC sections of IND or CTA submissions Working knowledge of viral vector platforms such as AAV or lentiviral systems