Associate Director, Global Regulatory Affairs

Summary

Join Telix Pharmaceuticals, a global radiopharmaceutical company, as an Associate Director, Global Regulatory Affairs. You will be responsible for ensuring regulatory objectives align with corporate goals, executing global regulatory strategies, and ensuring dossier compliance for assigned products. This role involves leading regulatory agency interactions, preparing regulatory submissions, monitoring global health authority regulations, and providing regulatory assessments for change management. The ideal candidate will have a scientific undergraduate degree, 7+ years of experience in pharmaceutical regulatory affairs, and direct experience in writing regulatory sections for global health authority applications. Telix offers a supportive work environment, competitive salaries, bonuses, equity incentives, generous vacation time, wellness days, and support for learning and development.

Requirements

• Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required
• 7+ years’ experience in regulatory affairs for pharmaceuticals products
• Direct experience in writing regulatory sections for global health authority applications (i.e., IND/IMPD, BLA/MAA)
• 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 publications
• Experience working globally in the US and EMEA

Responsibilities

• Prepare and execute, 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
• Represent regulatory affairs on project teams as a subject matter expert by providing guidance and regulatory expertise to other departments in support to product development
• Lead regulatory agency interactions including, but not limited to, coordination of redaction of briefing package, preparation of meeting minutes and responses to agencies questions
• Prepare, review, analyses, and consolidate 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, BLA/MAA)
• Provide 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
• Monitor global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, Therapeutic Goods Authority to maintain regulatory submission compliance
• Lead regulatory interaction with health authorities for IND and BLA filings (or equivalent)

Preferred Qualifications

• Advanced degree preferred
• Direct experience in Radiopharmaceuticals, biologicals, and/or clinical preferred
• Experience across product development to Marketing Authorization

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development