Core ResponsibilitiesDevelop, implement, and maintain clinical SOPs, policies, work instructions, and templatesEnsure SOPs align with global regulatory requirements (e.g., FDA, EMA, ICH GCP, MHRA)Manage SOP lifecycle activities including authorship, review, approval, training, and periodic reviewProvide QA oversight for clinical trials conducted by CROs, vendors, and investigative sitesSupport risk-based quality management (RBQM) activities, including qual
Core ResponsibilitiesDevelop, implement, and maintain clinical SOPs, policies, work instructions, and templatesEnsure SOPs align with global regulatory requirements (e.g., FDA, EMA, ICH GCP, MHRA)Manage SOP lifecycle activities including authorship, review, approval, training, and periodic reviewProvide QA oversight for clinical trials conducted by CROs, vendors, and investigative sitesSupport risk-based quality management (RBQM) activities, including qual
About company: A pre-IPO biotech Key Responsibilities:1) Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval.Ensure strategies are aligned with regulatory requirements (FDA, EMA, PMDA, NMPA, etc.), corporate goals, and scientific development plans.2) Regulatory Submission Leadership: Serve as the Regulatory CMC Lea
About company: A pre-IPO biotech Key Responsibilities:1) Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval.Ensure strategies are aligned with regulatory requirements (FDA, EMA, PMDA, NMPA, etc.), corporate goals, and scientific development plans.2) Regulatory Submission Leadership: Serve as the Regulatory CMC Lea
The client is an early-stage company backed by leading investors and experienced biotech executives. Key Responsibilities:1. Lead the expression, purification, and characterization of antibody-based therapeutics (monospecifics, bispecifics, Fc fusions, and conjugates). 2. Drive innovation in biologics production — including heterodimerization control, conjugation (enzymatic, click, or linker-based), and modular payload formats (peptide, oligo, or protein).
The client is an early-stage company backed by leading investors and experienced biotech executives. Key Responsibilities:1. Lead the expression, purification, and characterization of antibody-based therapeutics (monospecifics, bispecifics, Fc fusions, and conjugates). 2. Drive innovation in biologics production — including heterodimerization control, conjugation (enzymatic, click, or linker-based), and modular payload formats (peptide, oligo, or protein).