Vera Therapeutics, Inc.
biotechnology
SeniorManager,RegulatoryCMC
“Senior Manager, Regulatory CMC at Vera Therapeutics, Inc.. Skills: Regulatory Affairs, CMC, Biologics. Manage CMC aspects of clinical products. Author and review CMC modules”
Industry & Context.
problem-solving skills
What They're Looking For.
Must Have
knowledge and experience in interpretation of global regulatory requirements, organizational skills, ability to track multiple timelines in parallel, manage deadlines, Excellent written and verbal communication, ability to collaborate across functions, problem-solving skills, attention to detail, Experience communicating regulatory strategies to stakeholders, Demonstrated regulatory affairs experience commensurate with the BAS in a scientific field, minimum 6 years of relevant experience
Nice to Have
Industry experience in CMC development of biologics, Experience with a regulatory information management system, such as Veeva Vault RIM
What You'll Do.
Manage CMC aspects of clinical products
Author and review CMC modules
Represent Regulatory Affairs on cross-functional teams
Evaluate proposed manufacturing changes
Establish and implement internal regulatory processes
and prioritize regulatory activities
Determine risk assessment
Ensure regulatory compliance
How You'll Work.
Team & Collaboration
working with the cross-functional team; Represent Regulatory Affairs on cross-functional project teams; collaborate across functions
Communication Scope
Excellent written and verbal communication; Experience communicating regulatory strategies to stakeholders
Process & Methodology
track multiple timelines in parallel, manage deadlines, Coordinate, track, and prioritize regulatory activities
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