Compliance Analyst supporting BeyondTrust’s cybersecurity SaaS compliance and vendor risk programs. Coordinating evidence, questionnaires, audits, policies, and cross - functional security projects.
About the role
- Regulatory Affairs Manager authoring CMC dossiers and global submissions for Telix’s radiopharmaceutical and biopharmaceutical pipeline. Supporting products for cancer and rare diseases.
Responsibilities
- 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
- 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
- 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
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