Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will support global regulatory activities across innovative oncology development programs. This role provides regulatory leadership at both molecule and study levels, helping shape strategies and guide submissions throughout the clinical development lifecycle. You will collaborate closely with clinical, technical, and cross-functional teams to prepare high-quality regulatory submissions and manage interactions with health authorities. The position offers significant exposure to FDA and international regulatory processes, including clinical trial applications, INDs, BLA and MAA filings, and health authority meetings. You will also help identify regulatory risks, coordinate responses, and ensure commitments and timelines remain on track. This is an opportunity to contribute to programs addressing significant unmet medical needs while working in a fast-paced, collaborative, and globally oriented environment.

Accountabilities:

• Provide regulatory guidance to project teams and key study-level sub-teams, interpreting regulatory requirements and advising on appropriate actions.
• Develop and implement competitive global regulatory strategies for assigned programs and identify potential regulatory risks, mitigation measures, and opportunities.
• Own regulatory activities at the molecule and study levels, including clinical trial applications, IND submissions, investigator document packages, FDA submissions, and other regulatory activities.
• Manage regulatory submission processes, timelines, tracking tools, documentation, archives, and related infrastructure.
• Monitor and manage regulatory agency queries and commitments, coordinating with subject matter experts to develop timely and appropriate written responses.
• Provide regular regulatory status updates, including progress against outstanding conditions, commitments, submissions, and approvals.
• Contribute to and take ownership of regulatory content and strategy for BLA and MAA filings, including dossier development, submission timelines, and regulatory queries.
• Serve as a regulatory liaison with the FDA for health authority meetings and lead preparation of meeting requests, briefing packages, cross-functional preparation sessions, responses, and meeting activities.
• Ensure regulatory submissions are complete, consistent, accurate, and compliant with applicable requirements and internal standards.
• Present regulatory updates during study team meetings and communicate the interpretation and practical application of regulatory requirements.
• Demonstrate strong knowledge of oncology, including lung cancer and other relevant indications, to support regulatory strategy and development activities.
• Oversee labeling-related meetings and activities as required.
• Lead processes for regulatory submissions to be reviewed, finalized, and approved for submission.
• Maintain accurate records of regulatory and ethics submissions, approvals, commitments, and key milestones across studies.
• Manage regulatory document archiving processes and provide appropriate cross-coverage when team members are unavailable.
• Support onboarding and training of new employees as needed, as well as department-wide initiatives, training programs, and other non-program-specific projects.
• Perform additional duties and responsibilities as assigned.

Requirements:

• Bachelor's degree in Biotechnology, Biological Sciences, or a related field required; a graduate degree such as an MS, PhD, or PharmD is preferred.
• At least 5 years of relevant regulatory affairs experience within the biopharmaceutical or pharmaceutical industry.
• Strong knowledge of U.S. FDA and international pharmaceutical regulations, guidance, drug development processes, and industry-standard regulatory practices.
• Demonstrated experience working in complex, matrixed organizations and collaborating with multiple internal and external stakeholders.
• Proven experience interacting directly with regulatory agencies and health authorities.
• Experience supporting global regulatory strategies and submissions throughout clinical development.
• Experience with INDs, CTAs, FDA submissions, and regulatory activities associated with clinical studies.
• Experience contributing to BLA or MAA filings and managing regulatory dossiers and related agency queries.
• Experience working with CROs on ex-U.S. CTAs and clinical trial activation activities is preferred.
• Experience supporting ex-U.S. health authority interactions and meetings is desirable.
• Strong clinical foundation and understanding of relevant disease landscapes, particularly oncology.
• Excellent written and verbal English communication skills, with the ability to clearly communicate complex regulatory matters.
• Strong negotiation, influencing, and consensus-building abilities, including the capacity to work proactively and effectively under pressure.
• Excellent organizational skills with the ability to prioritize, manage, and delegate multiple projects and regulatory activities.
• High attention to detail and a strong commitment to accuracy, compliance, and quality.
• Proficiency with Microsoft Office applications such as Word and Excel.
• Experience with electronic document management systems and document review tools is preferred.
• Knowledge of Chinese is desirable.

Benefits:

• Base salary range of $168,000–$198,000 USD.
• Total compensation may also include bonus, stock, benefits, and other applicable variable compensation.
• Fully remote position within the United States.
• Opportunity to contribute to global oncology programs addressing significant unmet medical needs.
• Exposure to complex international regulatory strategies and health authority interactions.
• Collaboration with multidisciplinary teams across clinical development and regulatory functions.
• Opportunities to develop expertise across major regulatory submissions and clinical development milestones.
• Professional growth in a fast-paced, collaborative, and globally oriented biopharmaceutical environment.