Scientist III, CMC

What you'll do

• Develop regulatory strategies and execution plans for pre-approval, post-approval changes, and lifecycle management activities.
• Serve as an author strategist by defining document structure and content strategy for complex regulatory dossiers.
• Author, review, and approve high-quality regulatory documents including supplements, variations, and health authority query responses.
• Provide strategic input on CMC and lifecycle change assessments, including risk evaluations and submission pathways.
• Act as the primary consultant and point of contact for client projects to provide guidance and maintain relationships.
• Lead timeline planning and tracking to ensure all regulatory deliverables meet critical milestones.
• Perform advanced document quality control and formatting in compliance with global regulatory standards.
• Mentor junior staff by providing technical guidance on regulatory strategy, authoring, and submission processes.

What we're looking for

• BS/MS degree in Chemistry, Analytical Chemistry, or a related life sciences field.
• Advanced experience in pharmaceutical product development, quality assurance, and/or CMC regulatory affairs (preferred).
• Knowledge and experience with cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations including FDA, EMA, and Health Canada.
• Experience writing global regulatory applications in CTD format.
• Proficiency in Microsoft Office Suite and Adobe Acrobat for document editing and formatting.
• Ability to work independently in a client-facing consultant capacity while managing multiple tasks.
• Strong written and verbal communication skills with an ability to mentor junior staff.