Apply on Employer Site

Telix Pharmaceuticals Limited · 2 hours ago

Senior Manager, Global Regulatory Affairs - CMC

United States

Full-time

Remote

Senior Level, Lead/Staff

9+ years exp

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with a mission to deliver on the promise of precision medicine through targeted radiation. The Senior Manager, Global Regulatory Affairs - CMC will be responsible for authoring CMC specific regulatory dossiers and ensuring compliance with global regulatory requirements for the development and commercialization of radiopharmaceutical and biopharmaceutical products.

Biotechnology

Responsibilities

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

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

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

Qualification

CMC regulatory knowledgeRegulatory submissionsTechnical writingAnalytical skillsCross-functional collaborationResilienceCommunication skillsInterpersonal skillsAdaptabilityContinuous learning

Required

Undergraduate degree required

9+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry

Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations

Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders

Good analytical and problem-solving skills, with the 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, data into appropriate sub-sections of Module 3

Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected

Driven to achieve goals and objectives, with a strong focus on delivering measurable results

Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders

Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges

Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals

Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges

Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills

Preferred

Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field

Benefits

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Company

Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals.

Founded in 2015

Melbourne, Victoria, AUS

1001-5000 employees