Scientist III - CMC

Responsibilities

• Develop regulatory strategy and execution plan for pre-approval, post-approval changes and lifecycle management activities.
• Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers.
• Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor.
• Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways.
• Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content.
• Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role.
• Lead timeline planning, tracking, and execution of regulatory deliverables to meet critical milestones.
• Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat.
• Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes.
• Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards.
• Promote best practices in document preparation, quality, and regulatory compliance across the team.
• Support regulatory inspections, audits, and responses related to lifecycle management activities, as needed.
• Ensure an established level of billable hours per fiscal year.

Qualifications

• Advanced experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred.
• Proactive, self-motivated, and able to work independently in a client-facing role.
• Knowledge and experience with cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.).
• Experience with writing global regulatory applications in CTD format.
• Ability to manage multiple tasks and meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Proficiency with Adobe Acrobat for document editing, formatting, and publishing.
• Team-oriented mindset with the ability to collaborate across functions.
• Understanding and application of scientific principles and techniques used in pharmaceutical product development.
• MS/BS in Chemistry, Analytical Chemistry, or related life sciences.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Contributes to the development of policies and procedures.
• Works on complex projects of large scope.
• Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
• Completes work independently with attention to detail.
• Receives general guidance on new projects.
• Works on projects with varying levels of complexity.
• Works on projects with a high degree of autonomy.
• Works on projects with a high degree of responsibility.
• Works on projects with a high degree of accountability.
• Works on projects with a high degree of innovation.
• Works on projects with a high degree of collaboration.
• Works on projects with a high degree of problem-solving.
• Works on projects with a high degree of creativity.
• Works on projects with a high degree of flexibility.
• Works on projects with a high degree of adaptability.
• Works on projects with a high degree of responsiveness.
• Works on projects with a high degree of initiative.
• Works on projects with a high degree of leadership.
• Works on projects with a high degree of mentoring.
• Works on projects with a high degree of coaching.
• Works on projects with a high degree of development.
• Works on projects with a high degree of growth.
• Works on projects with a high degree of learning.
• Works on projects with a high degree of improvement.
• Works on projects with a high degree of enhancement.
• Works on projects with a high degree of optimization.
• Works on projects with a high degree of efficiency.
• Works on projects with a high degree of effectiveness.
• Works on projects with a high degree of productivity.
• Works on projects with a high degree of performance.
• Works on projects with a high degree of excellence.
• Works on projects with a high degree of quality.
• Works on projects with a high degree of value.
• Works on projects with a high degree of impact.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
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• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence.
• Works on projects with a high degree of influence