Specialist, Global Regulatory Affairs

il y a 3 semaines


Liège, Belgique Telix Pharmaceuticals (EMEA) Temps plein

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**

Telix is currently seeking a Specialist to join our Global Regulatory Affairs team in Europe. This position is responsible for the preparation and the execution of the regulatory strategy and dossier compliance for dedicated products in EMEA region.

**Key Accountabilities**:

- Prepares and executes, in collaboration with other regulatory affairs team members, global regulatory strategies and submission requirements pertaining to assigned projects in line with Telix's objectives and initiatives
- Interacts with appropriate national/regional regulatory agencies
- Provides regulatory expertise for EMEA region
- Monitors EMEA health authority regulations, guidelines, and specifications to maintain regulatory submission compliance
- Performs any other regulatory tasks assigned by the manager

**Education and Experience**:

- Undergraduate degree with a focus in life sciences required
- 3+ years of regulatory affairs experience in the pharmaceutical industry required
- Experience in EU regulatory affairs is a must
- Experience in centralized procedures, MA transfer, life-cycle management is a must
- Experience in UK and Swiss procedures is a plus
- Experience in radiopharmaceuticals and/ or oncological products is a plus
- Good written and verbal communication skills in English

**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

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 RECRUITMENT PRIVACY POLICY HERE



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