VICE PRESIDENT OF REGULATORY AFFAIRS | G-110

This clinical-stage biotech company is developing small molecule therapeutics for the treatment of devastating cancers and immune disorders. they are seeking a vice president of regulatory affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. you will provide crucial input to the organization to advance the pipeline and help them to get new drugs approved. this company offers a collaborative, science-driven culture and flexible work arrangements. with multiple programs in clinical trials and a rapidly growing clinical portfolio, now is an exciting time to join this growing organization! responsibilities: develop and lead regulatory strategies for a portfolio of oncology and immunology programs. serve as primary contact with fda and other regulatory agencies, leading all communications and meetings. coordinate and manage regulatory submissions (e.g. inds, clinical trial applications, marketing applications) in collaboration with multi-disciplinary development teams as well as senior management represent regulatory affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at cros and consultants to coordinate regulatory submissions. ensure on-time, high-quality and regulatory–compliant submissions. lead regulatory meeting preparation efforts supported by the project team; build and lead the regulatory affairs function to ensure adherence to regulatory standards and requirements for the company. hire and manage direct reports and consultants,...