Associate Director, Regulatory Affairs

Accountabilities: Provide scientific and biological regulatory guidance to project teams and clinical study sub-teams, applying knowledge of biological therapeutics and relevant regulatory requirements. Develop and implement global regulatory strategies for the investigational therapy, considering scientific evidence, regulatory expectations, potential risks, and mitigation approaches. Independently manage regulatory activities at the molecule and clinical study levels, including Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions. Review and approve investigator document packages and related FDA submissions, ensuring accuracy and regulatory compliance. Interpret applicable government regulations and scientific guidance to address regulatory requirements throughout clinical development. Communicate study-level regulatory strategies and activities to project teams, helping stakeholders understand and apply relevant requirements. Build and maintain effective relationships with regulatory agencies and subject matter experts, coordinating responses to agency questions and tracking regulatory commitments. Contribute to and take ownership of the scientific and regulatory content and strategy supporting Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs). Manage regulatory timelines, submission dossiers, agency queries, and supporting documentation to ensure submissions are complete, accurate, and consistent. Serve as a key liaison with the FDA for health authority meetings, leading cross-functional preparation of meeting requests, briefing packages, responses, and regulatory defense materials. Coordinate and lead health authority meetings and related discussions concerning the clinical development and regulatory status of the therapeutic. Ensure regulatory submissions meet applicable standards for scientific consistency, completeness, quality, and compliance. Apply knowledge of lung cancer and other relevant therapeutic indications to regulatory oversight and clinical development activities. Oversee labeling meetings and ensure appropriate consideration of scientific, clinical, and regulatory requirements. Direct the review, finalization, and approval of regulatory submissions, coordinating stakeholder input and sign-off. Maintain records of regulatory and ethics submissions and approvals across clinical studies. Oversee regulatory document archiving to ensure accurate maintenance, organization, and accessibility of records. Provide cross-functional coverage when colleagues are unavailable and support onboarding and training on regulatory processes and submission procedures. Contribute to departmental initiatives, scientific and regulatory training, and other non-program-specific projects. Requirements: Bachelor's degree in Biotechnology, Biological Sciences, or a related field required. A graduate-level qualification, such as an MS, PhD, or PharmD, is preferred. At least 5 years of regulatory affairs experience within the biopharmaceutical industry. Strong knowledge of US FDA and international pharmaceutical regulations, regulatory guidance, drug development processes, and industry-standard practices. Experience managing regulatory activities for clinical development programs, including IND and CTA submissions. Demonstrated experience interacting with health authorities and government regulatory agencies. Ability to work effectively in complex, matrixed environments and coordinate multiple stakeholders across functions and geographies. Strong scientific and clinical foundation, with an understanding of relevant disease areas and oncology development. Excellent written and verbal communication skills in English, including the ability to prepare regulatory documentation and communicate complex scientific information clearly. Strong negotiation, influencing, and consensus-building skills, with the ability to work proactively and effectively under pressure. Excellent organizational skills, attention to detail, and the ability to prioritize and manage multiple projects and deadlines. Experience working with Contract Research Organizations (CROs) on ex-US CTA submissions, clinical trial activation, and international health authority interactions is preferred. Proficiency in Microsoft Office applications, particularly Word and Excel. Familiarity with electronic document management systems and document review tools is desirable. Knowledge of Chinese is an additional advantage. Benefits: Annual base salary range of $168,000–$198,000 USD. Potential eligibility for bonus compensation, stock awards, and other variable compensation. Total compensation determined according to relevant skills, experience, certifications, and work location. Remote work arrangement within the United States. 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