Associate Director, Global Regulatory Affairs

The Associate Director, Global Regulatory Affairs is primarily responsible for ensuring regulatory objectives are met and align with Telixs corporate objectives. This person is responsible for the execution of global regulatory strategy and dossier compliance within 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 projects in line with Telixs 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 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).
• 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 (chemistry, biology, pharmaceutical sciences) required; Advanced degree preferred
• 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)
• Direct 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 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

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