Drive CMC regulatory strategy as a Senior Associate Director. Lead teams in developing and executing compliant strategies for biologics across all clinical stages while managing critical timelines.
You will play a pivotal role in shaping CMC strategy and ensuring all regulatory submissions meet health authority standards. Collaborating with manufacturing and quality teams, your work will greatly influence project success for biologics programs from pre-clinical through Phase 3 studies. Your leadership in evaluating regulatory risks and providing thorough guidance will enhance project outcomes.
Key Responsibilities:
• Serve as the lead regulatory representative • Oversee CMC submission preparations and filings • Manage interactions with regulatory agencies • Collaborate with external partners for guidance • Assess and mitigate CMC program risks
Requirements: • In-depth knowledge of CMC regulations • Familiarity with eCTD structure for submissions • 12 years of related work experience is necessary • Background in biological or pharmaceutical sciences • Exceptional oral communication and writing skills
Elevate product development by leveraging your extensive regulatory knowledge and strategic guidance in biologics programs. #J-18808-Ljbffr
Apply on Kit Job: kitjob.ca/job/2g9br7
📌 Senior CMC Regulatory Affairs Leader (West Vancouver)
🏢 Scorpion Therapeutics
📍 West Vancouver
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