Regulatory Affairs Manager

About the role

Our client, a clinical-stage biopharmaceutical company, is seeking a Regulatory Affairs leader to provide strategic regulatory guidance for its research and development programs, including regulatory strategy development and execution, health authority interactions, and oversight of regulatory submission planning.

Responsibilities

• Provide strategic regulatory leadership and guidance to cross-functional development teams, evaluating the regulatory implications of clinical protocol design, CMC changes, and labeling strategies to support development, approval, and lifecycle management with U.S. and ex-U.S. regulatory authorities
• Monitor global regulatory developments and assess potential impact on the company's operations and development programs, keeping leadership informed of compliance risks, strategic opportunities, and required actions
• Lead or oversee planning, preparation, and submission of regulatory lifecycle management activities (e.g., Annual IND Reports and other filings) to the FDA and international regulatory authorities; review and approve regulatory content for strategic alignment, compliance, and timeliness
• Oversee development of regulatory briefing packages and meeting materials summarizing efficacy/safety data, proposed study designs, and key questions to support productive regulatory interactions
• Provide oversight of regulatory vendors and CROs responsible for submission preparation, dossier compilation, publishing, and related regulatory operations
• Maintain accountability for vendor performance, submission quality, regulatory compliance, budget management, and timely execution of deliverables

Qualifications

• PhD, PharmD, or Master's degree in Regulatory Affairs, Pharmacology, Chemistry, Biology, or related scientific discipline preferred; Bachelor's degree considered with substantial regulatory affairs experience in pharma/biotech
• RAC certification (RAPS) preferred, U.S. focus; combined U.S./EU certification strongly preferred
• Demonstrated ability to collaborate cross-functionally and build productive relationships with internal and external stakeholders
• Excellent analytical, organizational, written, and verbal communication skills; able to manage multiple priorities in a dynamic environment
• Ability to analyze and synthesize complex scientific and regulatory information, communicate across functions and levels, and influence decision-making in a matrixed environment