Manager, Regulatory Affairs (CMC)

Telix Pharmaceuticals (AMER); United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Manager, Regulatory Affairs (CMC) to author CMC dossiers and drive global regulatory submissions for radiopharmaceutical products. You will write Module 3, coordinate Module 2.3 & Module 3 documents, and ensure regulatory compliance across programs from early to post-approval.

The role requires advanced regulatory knowledge, strong technical-writing abilities, and cross-functional collaboration with QA, manufacturing and preclinical teams.

Qualifications

• Strong technical writing and verbal communication skills for complex regulatory issues.
• Experience with global regulatory submissions and ICH guidelines.
• Background in CMC for radiopharmaceuticals or biopharmaceuticals is preferred.

Responsibilities

• Author/write CMC sections (Module 3) and plan/draft regulatory dossiers.
• Coordinate modules 2.3 & 3 for INDs, NDAs, BLAs, MAAs, CTAs and post-approval submissions.
• Ensure regulatory compliance and stay current with ICH, FDA and EMA guidance.
• Collaborate with QA, manufacturing and preclinical teams on CMC scope and content.
• Assess manufacturing changes and perform comparability assessments when needed.

Skills

Regulatory writing

Regulatory submissions

Communication skills

Analytical skills

Regulatory knowledge

Cross-functional collaboration

Regulatory risk management

Technical writing

Education

Bachelor's degree

Advanced degree (MSc/PhD) preferred

Tools

Veeva

Job description

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, Regulatory Affairs (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 Regulatory Affairs (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.

Position Requirement

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

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out 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.

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