Associate Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer regulatory guidance to project teams and critical study-level sub-teams.

• Evaluate, formulate, and execute competitive global regulatory strategies for ivonescimab.

• Recognize regulatory risks, develop mitigation strategies, and propose solutions.

• Take ownership of molecule- and study-level regulatory tasks, including CTA and IND submissions.

• Review and authorize investigator document packages and related FDA submissions.

• Oversee regulatory submission processes, timelines, tracking tools, archives, and infrastructure.

• Present regulatory activities and clarify regulatory requirements for study teams.

• Handle regulatory agency inquiries and commitments, collaborating with subject matter experts on written responses.

• Manage regulatory content and strategy for BLA or MAA filings.

• Monitor timelines, regulatory dossiers, and regulatory inquiries.

• Act as the FDA Health Authority liaison for meetings.

• Organize regulatory meeting requests and packages, coordinate cross-functional preparation, and lead responses and meetings.

• Ensure regulatory submissions are consistent, thorough, and compliant with standards.

• Utilize expertise in lung cancer and other relevant indications.

• Supervise labeling meetings.

• Lead the review, finalization, and approval processes for regulatory submissions.

• Track regulatory and ethics submissions and approvals across studies.

• Manage document archiving processes.

• Provide cross-coverage and train new employees as necessary.

• Support departmental initiatives and training programs.

• Carry out other assigned responsibilities.

⛳️ Requirements

• BA/BS degree in Biotechnology, Biological Sciences, or a related field is required.

• A minimum of 5+ years of experience in regulatory affairs is necessary.

• Relevant experience in the biopharmaceutical industry is essential.

• Strong knowledge of US FDA and international pharmaceutical guidelines, regulations, drug development processes, and industry-standard practices.

• Experience working in a complex, matrix environment with multiple stakeholders.

• Proficient in interfacing with government regulatory agencies and Health Authorities.

• Excellent written and oral communication skills in English.

• Strong negotiation capabilities and the ability to work effectively under pressure and proactively.

• Solid clinical background and understanding of the disease landscape.

• Detail-oriented with the ability to organize, prioritize, and delegate tasks effectively.

• Global regulatory experience is required.

• Knowledge of Chinese is a plus.

• Preferred experience in managing ex-US CTAs and interactions with ex-US Health Authorities while collaborating with CROs.

• Proficient in MS Office suite, electronic document management systems, and document review tools is desirable.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Benefits and/or other applicable variable compensation.

• Commitment to Equal Opportunity Employment and nondiscrimination in recruitment, hiring, training, and promotion.