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: 

• Provide scientific and biological regulatory guidance to project teams and key sub-teams at the clinical study level, applying knowledge of biological sciences and the regulatory requirements governing the clinical development of biological therapeutics. 

• Assess, develop, and implement competitive global regulatory strategies for ivonescimab, taking into consideration the biological and scientific aspects of the therapeutic, applicable regulatory requirements, and potential risks and mitigation strategies. 

• Independently manage regulatory activities at the molecule and clinical study levels, including Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions; review and approve investigator document packages and associated FDA submissions; and oversee other day-to-day regulatory activities associated with the clinical development of the biological therapeutic. 

• Apply broad scientific, biological, and technical knowledge, together with an understanding of applicable government regulations, in evaluating and addressing regulatory requirements throughout the clinical development process. 

• Present and communicate study-level regulatory activities to project teams, providing interpretation and application of regulatory requirements in the context of the scientific and biological aspects of the clinical studies. 

• Maintain effective working relationships with regulatory agencies and subject matter experts to coordinate written responses to agency queries, track regulatory commitments, and communicate progress on outstanding conditions and commitments relating to the clinical development and regulatory oversight of the therapeutic. 

• Serve as a key contributor and assume ownership of the scientific and regulatory content and strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings. 

• Track regulatory timelines, maintain responsibility for the regulatory dossier, and manage regulatory queries to ensure the accurate and complete presentation of the scientific and regulatory information supporting the therapeutic. 

• Serve as Summit's liaison with the FDA for health authority meetings. Lead cross-functional teams in preparing regulatory meeting requests, meeting packages, and responses to agency queries; coordinate and lead regulatory defense preparation sessions and health authority meetings concerning the clinical development and regulatory status of the therapeutic. 

• Ensure the scientific and regulatory consistency, completeness, and adequacy of regulatory submissions and their adherence to applicable regulatory requirements and submission standards. 

• Demonstrate expertise and knowledge of lung cancer and other therapeutic indications as needed, applying such knowledge in connection with the regulatory oversight and clinical development of the therapeutic. 

• Oversee labelling meetings as required, ensuring appropriate consideration of applicable scientific, clinical, and regulatory requirements. 

• Direct and coordinate the review, finalization, and sign-off of regulatory submissions to ensure the completeness and adequacy of the scientific and regulatory information presented. 

• Maintain and oversee the record of regulatory and ethics submissions and approvals across all clinical studies. 

• Manage document archiving processes to ensure the appropriate maintenance and accessibility of scientific and regulatory documentation. 

• Provide cross-coverage when other team members are on leave and train new employees as needed on regulatory processes, applicable scientific and biological regulatory requirements, and submission procedures. 

• Support non-program-specific projects, including departmental initiatives, scientific and regulatory training, and other related activities. 

• 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 Education