ClinChoice
Pharma
SeniorAssociate/Strategist–RegulatoryAffairs(APACCMC)
“Senior Associate/Strategist – Regulatory Affairs (APAC CMC) at ClinChoice. Skills: Regulatory Affairs, CMC Regulatory, Technical Writing. Author regulatory submissions. Review CMC sections”
What You'll Achieve.
Timely completion of submissions
Industry & Context.
Identify potential CMC Regulatory issues; Propose mitigation strategies
What They're Looking For.
Must Have
Bachelor's degree or higher, 5-9 years relevant experience, Authoring CMC sections, Technical writing expertise, Knowledge of CMC regulatory requirements, Experience with eCTD format
Nice to Have
Background in pharmaceutical manufacturing, Background in quality control
What You'll Do.
Author regulatory submissions
Ensure regulatory compliance
Collaborate with SMEs
Maintain document quality
Identify CMC regulatory issues
Propose mitigation strategies
Interpret regulations
Guide teams on regulations
How You'll Work.
Team & Collaboration
Subject matter experts; Scientists; Quality assurance; Manufacturing teams; Regulatory affairs colleagues; Cross-functional teams
Communication Scope
Communication skills; Technical writing; Editing
Process & Methodology
Manage projects
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