Associate Manager, Regulatory Affairs

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Regulatory affairs Associate Manager manages, evaluates, and completes regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Associate manager will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical. Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned pro...