Associate Director, Regulatory Affairs

Overview of Role: 

The Associate Director of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory environment.  Global regulatory experience is required. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned. 

Role and Responsibilities: 

• Provides regulatory guidance on project teams and key sub-teams at study level 

• Assess, develop, and implement competitive global regulatory strategies for ivonescimab, and identify potential risks and mitigation steps with proposed strategies 

• Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other day-to-day regulatory activities of the studies as necessary and independently 

• Broadly applies regulatory/technical knowledge of government regulations and skills 

• Present and inform study team of regulatory activities at study team meetings and provide interpretation and application of regulatory requirements 

• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions and/or commitments 

• Key contributor and owns the regulatory content and strategy for BLA or MAA filings 

• Tracks the timelines, responsible for the regulatory dossier and manages the regulatory queries 

• Health authority (HA) meetings:  Serves as health authority (HA) liaison with FDA for meetings.  Prepares and leads project team in the planning of regulatory meeting request and meeting package, coordinates and leads cross-functional regulatory defence preparation meetings, responses to health authority queries, and health authority meetings. 

• Ensure consistency, completeness, and adherence to standards for all regulatory submissions in accordance with regulatory requirements 

• Demonstrate expertise and knowledge of lung cancer and other indications as needed 

• Oversee labelling meetings as required 

• Lead processes by which regulatory submissions are reviewed, finalized, and signed-off 

• Manage the track record of regulatory/ethics submissions and approvals across all studies 

• Manage document archive processes 

• Provide cross-coverage when other members are on leave, and train new employees as needed 

• Support non-program specific projects, such as department initiatives, training, etc. 

• All other duties as assigned 

Experience, Education and Specialized Knowledge and Skills: 

• BA/BS degree in Biotechnology, Biological Sciences, or related field required; graduate-level degree, e.g., MS, PhD, or PharmD a plus 

• Relevant (bio) pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs 

• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices 

• Experience working in a complex and matrix environment, and with multiple stakeholders. Experience interfacing with government regulatory agencies. Experience working with Health Authority 

• Strong written, oral communications in English.  

• Strong negotiation skills, including ability to work under pressure and proactively, and build consensus cross-functionally and within regulatory affairs 

• Strong clinical foundation and understanding of disease landscape under consideration. 

• Experience in interfacing with regulatory health authorities 

• Knowledge of Chinese is desirable 

• Careful attention to detail; ability to organize, prioritize, and delegate assigned projects 

• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US HA interactions, meetings etc. 

• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable