Manager, Regulatory Affairs – CMC

Telix Pharmaceuticals Limited

. Author and write CMC-specific regulatory dossiers, including 3.2.S and 3.2.P sections .

Posted 11/3/2026full-timeRemote • Canada, United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring CMC-specific regulatory dossiers and developing ICH-aligned submissions, ensuring compliance with global regulatory requirements. Proficient in technical writing and collaboration across multidisciplinary teams to assess and mitigate regulatory risks.

Highest-signal resume keywords

CMC Regulatory Dossier AuthoringICH Guidelines ComplianceECTD Module 3 DocumentationRegulatory Risk AssessmentTechnical Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory RequirementsRegulatory Submission DevelopmentComparability AssessmentsPharmaceutical Manufacturing ReportsTechnical DocumentationRegulatory ComplianceData AnalysisProblem-SolvingRisk MitigationStakeholder Communication

Soft Skills

Analytical SkillsCollaborationEffective CommunicationAdaptabilityRelationship Building

Tools & Technologies

VeevaRegulatory Domain Systems

Industry Keywords

Biopharmaceutical IndustryRadiopharmaceuticalsFDA RegulationsEMA DirectivesINDsIMPDsNDAsBLAsMAAsCTAs

About the role

Key responsibilities & impact

Author and write CMC-specific regulatory dossiers, including 3.2.S and 3.2.P sections
Develop ICH-aligned CMC/technical portions of global regulatory submissions for early- to late-stage and post-approval programs
Plan and prepare or revise eCTD Module 2.3 and Module 3 documents for INDs, IMPDs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions
Ensure regulatory submission accuracy, completeness, and timely delivery
Plan, track, and clearly write Module 3 documentation using regulatory domain systems and processes such as Veeva
Monitor and interpret evolving CMC regulatory requirements, including ICH, US FDA CFRs, EMA Directives, and Annexes
Ensure CMC documentation and data comply with applicable regulations
Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams on CMC regulatory scope and content
Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes
Conduct comparability assessments and develop post-approval supplements as needed
Identify potential CMC regulatory risks and recommend mitigation plans

Requirements

What you’ll need

Undergraduate degree required
Advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or a related field preferred
7+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry
Solid understanding of global CMC regulatory requirements and guidelines, including ICH guidelines and FDA, EMA, and other health authority regulations
Excellent technical writing and verbal communication skills
Ability to communicate complex regulatory issues to internal and external stakeholders
Good analytical and problem-solving skills
Ability to assess and mitigate regulatory risks
Ability to work collaboratively and build effective relationships across functions and geographies
Skilled at summarizing pharmaceutical manufacturing and method development reports and data into appropriate Module 3 subsections
Ability to work in a dynamic environment, adjust to changing priorities, and take on new challenges
Commitment to ongoing learning and professional development

Benefits

Comp & perks

Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Hybrid and remote work arrangements are available across the company