Manager, Regulatory Affairs (Ad-Promo)

The posting, as Telix Pharmaceuticals (AMER) wrote it

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 (Ad-Promo), will provide strategic, operational, and tactical regulatory advice to internal stakeholders regarding advertising and promotion materials for investigational products and approved commercial products ensuring they comply with local laws and regulations and company policies, while supporting achievement of business objectives. Manages regulatory review of advertising and promotion materials, disease awareness and training materials, new campaigns, and product launch strategies for all markets. Supports the Senior Director, Regulatory Affairs (Labeling/Ad-Promo), in efforts to influence the regulatory environment.

Key Accountabilities

• Reviews proposed advertising and promotion materials and disease awareness materials, as assigned, to ensure compliance with applicable laws and regulations and internal policies while supporting commercial objectives. Supports review of materials for the U.S., Canada, Australia, the UK, Belgium, the Netherlands, Luxembourg, Spain, Germany, and other ex ‑ U.S. markets.
• Participates as the Regulatory Representative on the Materials Review Committee (MRC), collaborating with Medical Affairs, Legal, and Marketing colleagues to assess regulatory risk and provide regulatory input and recommendations on promotional and non‑ promotional materials.
• Manages regulatory advertising and promotion activities across assigned products.
• Manages and coordinates health authority submissions for promotional materials in markets where pre‑ clearance or notification is required, ensuring timely and compliant submissions in accordance with local regulatory expectations, including management of Form FDA 2253 for submissions in the U.S.
• Applies strong working knowledge of FDA regulations, OPDP guidance, and other requirements governing advertising and promotion of radiopharmaceutical products. Escalates issues, as appropriate.
• Monitors the evolving U.S. regulatory promotional landscape, including new FDA regulations and guidance, enforcement actions, and industry trends, and communicates key developments to internal stakeholders.
• Creates, maintains, and stores abbreviated Prescribing Information (aPI) in accordance with regulatory expectations.
• Serves as the regulatory point of contact for global, regional, and local brand teams for assi

[…]
s 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.

VIEW OUR PRIVACY POLICY HERE