Manager – Global Regulatory Affairs Labeling

See Yourself at Telix 

The Manager, Global Regulatory Affairs Labeling will work within Global Regulatory Affairs and with cross-functional product teams, subject matter experts, and key stakeholders to draft and maintain target product profiles (TPPs), target labeling, and prescription drug labeling throughout the product lifecycle (early development through post-approval) for Telix investigational and commercial products.

The individual will primarily be supporting regulatory labeling for our early development compounds: TLX300-Tx, TLX592-Tx, TLX66-Tx, TLX090-Tx, and TLX599-CDx/Sx. The individual may provide support, as needed, for TLX591-Tx, TLX101-Tx, TLX250-Tx, ILLUCCIX®, GOZELLIX®, ZIRCAIX®, and PIXCLARA®, and other products, as assigned.

Key Accountabilities:

• Independently (with little supervision) lead the development, revision, review, and approval of Target Product Profiles, Target Labeling, Company Core Data Sheets, and Local Labeling.
• Draft labeling content that is consistent with the company strategy for the product. Collaborate with internal and external colleagues to provide input into labeling documents.
• Resolve any labeling issues and coordinate approval by the Labeling Management Team.
• Ensure labeling documents are well-supported by other regulatory documentation (e.g., CSRs, Summary of Clinical Efficacy, Summary of Clinical Safety, etc.) in preparation for submission to Health Authorities.
• Make recommendations and provide advice and guidance on regulatory documentation to ensure the documents support the labeling.
• Draft labeling text for packaging components.
• Collaborate with internal and external colleagues on branding, logos, and design of packaging components.
• Coordinate artwork creation with manufacturing and supply chain and/or external vendors.
• Collaborate with Project Management and Global Regulatory Affairs representatives to define timelines for labeling deliverables and ensure those timelines are met.
• Ensure labeling documents are compliant with internal and external templates, internal standards, and external regulations and guidance.
• Maintain a high standard of attention to detail with a goal of zero errors in labeling documents meant for a prescriber or patient.
• Contribute to the continuous improvement of the end-to-end labeling process.

Education and Experience:

• BA/BS in scientific degree (chemistry, biology, pharmaceutical sciences) required. Advanced degree a plus.
• 5+ years’ experience in regulatory affairs labeling for pharmaceuticals products required
• Direct experience in writing Target Product Profiles, Target Labeling, Company Core Data Sheets, and local labeling such as USPIs and/or EU SmPCs
• Experience across product lifecycle (i.e., development to post-marketing)
• Comprehensive knowledge of the drug development process
• Ability to understand and interpret Federal, State and Local regulations and guidance documents as well as common and scientific and technical journals.

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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• 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
• 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, able to adjust to changing priorities, and willing to take on new 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
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills