Telix Pharmaceuticals (AMER)
Global Regulatory Affairs - CMC Talent Community
USA- Remote
Sponsorship not specifiedDetected 42 days ago
ComplianceFDA RegulatoryAnimal StudiesCommunicationCollaborationProblem SolvingWritingRegulatory Affairs
About the role
- Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
- You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
- Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities Telix is always looking to connect with great talent in the market!
Responsibilities
- Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
- Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine.
Requirements
- This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers.
Nice to have
- Undergraduate degree required
- Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
- Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
Skills
- Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
- Analytical
- Interpersonal
- Submit your information and let's stay connected!
- Telix Pharmaceuticals is an equal opportunity employer.
Compensation
- We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Benefits
- Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
- We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
- We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Company info
- Interested in joining our mission?
- At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity.
- You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.
Equal opportunity
- equal opportunity employer.
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