Manager, Global Regulatory Affairs - CMC

3M HEALTHCARE; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Telix Pharmaceuticals seeks a Manager, GRA - CMC to author Module 3 regulatory sections and support global submissions. You will work across QA, CMC/Manufacturing, and preclinical teams to ensure high-quality, compliant dossiers for INDs, NDAs, and post-approval variations.

Strong writing, regulatory knowledge, and collaboration are essential. Experience in radiopharmaceuticals/biopharmaceuticals and knowledge of ICH guidelines are required.

Qualifikationen

• Experience in regulatory writing for Module 3 across radiopharmaceutical/biopharmaceutical products.
• Ability to write high-quality regulatory dossiers aligned with ICH and global health authority requirements.
• Excellent communication and collaboration with QA, CMC/Manufacturing, and clinical teams.

Aufgaben

• Lead authoring of regulatory dossiers (Module 3) for radiopharmaceutical/biopharmaceutical products.
• Plan and coordinate regulatory submissions (INDs, NDAs, CTAs, MAAs, variations).
• Ensure documentation is compliant with current regulatory guidelines and company processes.
• Collaborate with cross-functional teams to define regulatory scope and content.

Kenntnisse

Regulatory writing

Cross-functional collaboration

Regulatory strategy

ICH guidelines

GxP awareness

Ausbildung

Undergraduate degree in Life Sciences

Advanced degree preferred

Tools

Veeva

eCTD

Jobbeschreibung

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. 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.

See Yourself at Telix

The Manager, GRA - CMC is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. The Manager RA CMC will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high‑quality, fit for purpose, and prepared in a timely manner across for early to late stage and post‑approval programs.

Key Accountabilities

• Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post‑approval supplements and variation submissions, ensuring accuracy and completeness.
• Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
• Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
• Cross‑Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
• Change Management: 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.
• Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.

Education and Experience

• 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.
• Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
• Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
• Analytical Skills: Good analytical and problem‑solving skills, with the ability to assess and mitigate regulatory risks.
• Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
• Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub‑sections of Module 3.

Key Capabilities

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Results‑oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills

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. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. 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.