Associate Director, Global Regulatory Affairs - Biologics

at  Telix Pharmaceuticals EMEA

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.

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.
• 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.
• Coordinates, reviews, analyses, and consolidates all relevant pharmaceutical and related technical information required for regulatory submission of the company’s investigational medicinal products with regulatory agencies (ODD, PIP/PSP, Scientific advices, IND/CTA…).
• 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 filings (ex: IND and pre-IND).

EDUCATION AND EXPERIENCE

• Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required; Advanced degree preferred
• 7+ years’ experience in regulatory for pharmaceuticals products with a focus on Biological products required
• Direct experience in writing regulatory sections for global health authority applications (i.e., IND/IMPD, BLA/MAA)
• Direct experience in Radiopharmaceuticals and/or clinical preferred
• Experience across product development (until Marketing Authorization) with a focus on Phases 1 and 2.
• Comprehensive knowledge of drug development process, biopharmaceutical technology, drug manufacturing processes, GMP and related issues
• Ability to understand and interpret any regional regulations and guidance documents as well as common and scientific and technical journals, along with other publications
• Experience working globally in the US and EMEA
  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.

Please refer the Job description for details