Manager, Regulatory Affairs (CMC)

Responsibilities

• 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.
• Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
• Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of 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 suggest mitigation plans to proactively manage issues.

Documentation and Systems

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.

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.