Regulatory Affairs Associate Director / Director with

The Role:

Drive regulatory strategies for current corporate portfolio and ensure alignment to regulatory goals with business objectives through cross-functional collaboration (e.g. R&D, Clinical, Quality, and Commercial teams)
Ensure successful submissions by overseeing accurate document preparation and interactions with health authorities; and represent company interests in regulatory agency interactions
Stay current on regulatory trends, share insights for informed decisions.
Conduct internal regulatory training as required, represent company as expert in industry forums, and lead regulatory team growth for peak performance.

Qualifications:

Relevant degree with 5+ years regulatory affairs experience within the biopharma industry, with track record in successful regulatory submissions and approval
Strong knowledge of global regulatory guidelines (FDA, EMA, etc.) and regulations
Previous experience in handling Oncology or related projects a plus.
Experience in AI-driven drug discovery or biotech is advantageous

BeathChapman Pte Ltd

Regulatory Affairs Associate Director / Director