Regulatory Senior Associate Chemistry, Manufacturing, Controls (CMC)
Core
Develop and implement regulatory strategies for small and large molecule pharmaceuticals, preparing submissions and liaising with health authorities.
Role type
Senior Associate Regulatory CMC Strategy
Builds
Global Regulatory Strategy Documents and Clinical Data Request (CTD) sections for regulatory submissions
Domain
Pharmaceutical industry, Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, CMC information assembly, Cross-functional collaboration, Submission standards compliance, Deficiency letter response management, Regulatory guideline interpretation, Project management, Risk mitigation
Preferred skills
Pharmaceutical industry experience, Regulatory information management systems proficiency, AI tool usage (e.g., ChatGPT, Microsoft Copilot), Analytical problem-solving
Technologies
Microsoft Office, Controlled documentation systems, Regulatory information management systems
Responsibilities
Contribute to project completion and manage time to meet targets, Support assembly of CMC information for global regulatory submissions, Actively contribute to cross-functional initiatives to mitigate risks, Ensure compliance with submission standards, procedures, and policies, Prepare and finalize Global Regulatory Strategy Documents and CTD sections, Maintain core dossiers and coordinate responses to deficiency letters, Review and apply regulatory guidelines for renewals, Recommend solutions and escalate issues with significant impact, Independently manage projects and execute strategies with minimal oversight, Collaborate with cross-functional teams to support regulatory strategies
Seniority
Senior, hands-on IC