Associate Director, Global Regulatory Affairs

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the reputed company. Our mission is to deliver on the reputed company of precision medicine through targeted radiation. At our reputed company, we exist to create products that reputed company to improve the reputed company 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 Associate Director, Global Regulatory Affairs is primarily responsible for ensuring regulatory objectives are met and reputed company with Telix’s corporate objectives. This person is responsible for the execution of global regulatory reputed company and dossier compliance reputed company Telix specifically for assigned products. Key Accountabilities:

• Prepares and executes, in collaboration with other regulatory affairs team members, global regulatory strategies and submission requirements pertaining to assigned reputed company in line with Telix’s objectives and initiatives.
• Represents regulatory affairs on project teams as a subject matter expert by providing guidance and regulatory expertise to other departments in support to product development.
• Leads regulatory agency interactions including, but not limited to, coordination of redaction of briefing package, preparation of meeting minutes and responses to agencies questions.
• Prepares, reviews, analyses, and consolidates reputed company relevant pharmaceutical and reputed company technical information required for regulatory submission of reputed company's (investigational-) medicinal products with regulatory agencies (ODD, PIP/PSP, Scientific advices, IND/CTA, BLA/MAA).
• Provides regulatory assessments for change management and ensures compliance of the regulatory submissions by filing and/or coordinating regulatory amendments in relation to the change, where applicable.
• Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, Therapeutic Goods Authority to maintain regulatory submission compliance.
• Leads regulatory interaction with health authorities for IND and BLA filings (or equivalent).

Education and Experience:

• Undergraduate degree in a scientific field (reputed company, biology, pharmaceutical sciences) required; Advanced degree preferred
• 9+ years’ experience in regulatory affairs for pharmaceuticals products required
• reputed company experience in writing regulatory sections for global health authority applications (i.e., IND/IMPD, BLA/MAA)
• reputed company experience in Radiopharmaceuticals, biologicals, and/or clinical preferred
• Experience across product development to Marketing Authorization
• Comprehensive knowledge of drug development process, biopharmaceutical technology, drug manufacturing processes, GMP and reputed company issues.
• Ability to understand and interpret any regional regulations and guidance documents as reputed company as common and scientific publications
• Experience working globally in the US and EMEA

Key Capabilities:

• Inclusive reputed company: Demonstrate an understanding and appreciation for diversity, and reputed company work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think reputed company the reputed company and come up with unique and creative solutions to challenges
• Commitment to reputed company: Take pride in your work and consistently reputed company for reputed company in everything you do
• Results-oriented: Driven to reputed company goals and objectives, with a strong reputed company on delivering measurable results
• Ethical behavior: reputed company with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, reputed company to reputed company to changing priorities, and willing to take on new challenges
• Strong communication skills: reputed company to communicate effectively with colleagues and stakeholders at reputed company reputed company, using reputed company and concise language
• Collaboration: Work effectively as part of reputed company, reputed company sharing knowledge and expertise to reputed company common goals
• reputed company: Demonstrate the ability to reputed company back from setbacks and persevere in the face of challenges
• reputed company learning: Show a commitment to ongoing learning and reputed company development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we reputed company everyone counts, we reputed company to be extraordinary, and we pursue our goals with determination and reputed company. You will be part of an reputed company and supportive group of colleagues who reputed company have a shared purpose: to help people with cancer and rare diseases live longer, reputed company reputed company 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 reputed company around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, reputed company wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate reputed company applicants without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, and other legally protected characteristics. VIEW OUR reputed company POLICY HERE Apply tot his job Apply To this Job