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 execution of the regulatory strategy and dossier compliance for dedicated products in the EMEA region.
Key Accountabilities:
1. 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.
2. Represents regulatory affairs on project teams as a subject matter expert by providing guidance and regulatory expertise to other departments in support of product development and product life-cycle management.
3. Interacts with appropriate national/regional regulatory agencies.
4. Prepares, reviews, analyzes, and consolidates all relevant pharmaceutical and related technical information required for regulatory dossier submission of the company's drug products with regulatory agencies (including but not limited to MA transfer, variation, and renewal applications).
5. Provides regulatory expertise for the EMEA region.
6. Monitors EMEA health authority regulations, guidelines, and specifications to maintain regulatory submission compliance.
7. Performs any other regulatory tasks assigned by the manager.
Education and Experience:
1. Undergraduate degree with a focus in life sciences required.
2. 3+ years of regulatory affairs experience in the pharmaceutical industry required.
3. Experience in EU regulatory affairs is a must.
4. Experience in centralized procedures, MA transfer, life-cycle management is a must.
5. Experience in UK and Swiss procedures is a plus.
6. Experience in radiopharmaceuticals and/or oncological products is a plus.
7. Good written and verbal communication skills in English.
Key Capabilities:
1. Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
2. Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
3. Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
4. Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
5. Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
6. Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
7. Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
8. Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
9. Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
10. Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.
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