Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will support and lead global regulatory activities for an innovative oncology therapeutic throughout its clinical development and commercialization preparation. This role combines scientific expertise, regulatory strategy, and cross-functional leadership to ensure submissions meet the requirements of health authorities worldwide. The successful candidate will manage regulatory activities across assigned clinical studies, including IND and CTA submissions, regulatory timelines, agency interactions, and dossier development. Working closely with clinical, scientific, and regulatory stakeholders, this professional will help shape regulatory strategies and ensure accurate, consistent documentation. The position also involves direct engagement with the FDA and other health authorities, as well as contributions to future BLA and MAA filings. This is an opportunity to make a meaningful contribution to the development of investigational oncology therapies addressing significant unmet medical needs.

• Bachelor's degree in Biotechnology, Biological Sciences, or a related field required.

• A graduate-level qualification, such as an MS, PhD, or PharmD, is preferred.

• At least 5 years of regulatory affairs experience within the biopharmaceutical industry.

• Strong knowledge of US FDA and international pharmaceutical regulations, regulatory guidance, drug development processes, and industry-standard practices.

• Experience managing regulatory activities for clinical development programs, including IND and CTA submissions.

• Demonstrated experience interacting with health authorities and government regulatory agencies.

• Ability to work effectively in complex, matrixed environments and coordinate multiple stakeholders across functions and geographies.

• Strong scientific and clinical foundation, with an understanding of relevant disease areas and oncology development.

• Excellent written and verbal communication skills in English, including the ability to prepare regulatory documentation and communicate complex scientific information clearly.

• Strong negotiation, influencing, and consensus-building skills, with the ability to work proactively and effectively under pressure.

• Excellent organizational skills, attention to detail, and the ability to prioritize and manage multiple projects and deadlines.

• Experience working with Contract Research Organizations (CROs) on ex-US CTA submissions, clinical trial activation, and international health authority interactions is preferred.

• Proficiency in Microsoft Office applications, particularly Word and Excel.

• Familiarity with electronic document management systems and document review tools is desirable.

• Knowledge of Chinese is an additional advantage.