Regulatory Affairs Manager, Consultant

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.

Key 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