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Manager, Global Regulatory Affairs – CMC
Telix Pharmaceuticals LimitedManager in Global Regulatory Affairs at Telix Pharmaceuticals focusing on CMC submissions and cross-functional collaboration with regulatory teams.
About the role
Key responsibilities & impact- Authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections)
- Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions
- Ensure Module 3 documentation is planned, tracked, clearly written
- Stay current and interpret evolving CMC regulatory requirements and guidelines
- Collaborate with internal stakeholders including Quality Assurance, CMC/Manufacturing, and preclinical teams
- Provide regulatory assessments for manufacturing changes
- Identify potential CMC regulatory risks and suggest mitigation plans
Requirements
What you’ll need- Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus 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 regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
- Excellent technical writing and verbal communication skills.
- Good analytical and problem-solving skills.
- Ability to work collaboratively and build effective relationships across functions and geographies.
- Skilled at summarizing pharmaceutical manufacturing and method development reports.
Benefits
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
ATS Keywords
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Hard Skills & Tools
CMC regulatory dossierseCTD Module 2.3eCTD Module 3regulatory assessmentstechnical writingpharmaceutical manufacturingmethod development
Soft Skills
analytical skillsproblem-solving skillscollaborationrelationship buildingcommunication skills
Certifications
Undergraduate degreeAdvanced degree (M.Sc., Ph.D.)