Director, Regulatory Sciences
Location: United States
Employment Type: Full-Time
Job Requisition ID: JR 8849
Posted: Recently
About ProPharma
For over two decades, ProPharma has supported biotechnology, pharmaceutical, and medical device organizations in advancing innovative therapies and accelerating product development. Through its proven advise–build–operate model, ProPharma delivers integrated, customizable solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, quality and compliance, and R&D technology.
Role Overview
The Director, Regulatory Sciences will provide strategic and operational leadership for U.S. regulatory science programs, overseeing regulatory submissions, client engagements, and high-performing regulatory teams. This role is critical to ensuring compliant, high-quality regulatory strategies and deliverables while supporting business growth and client success within the pharmaceutical and life sciences sectors.
Key Responsibilities
Regulatory Strategy and Leadership
Develop and execute U.S. regulatory strategies for submissions, approvals, and lifecycle maintenance in alignment with FDA requirements and organizational objectives.
Serve as a senior regulatory advisor for clients, providing strategic guidance across development programs and regulatory pathways.
Maintain up-to-date knowledge of evolving U.S. regulatory frameworks, FDA guidance, and industry best practices, including the Hatch-Waxman Act.
Team and Project Management
Lead, mentor, and develop a team of regulatory professionals, fostering a culture of excellence, accountability, and continuous improvement.
Oversee preparation, review, and timely submission of high-quality regulatory deliverables, ensuring accuracy, consistency, and compliance.
Manage multiple regulatory projects simultaneously, ensuring delivery within defined timelines and budgets.
Cross-Functional and External Collaboration
Collaborate closely with R&D, Manufacturing, Quality Assurance, Legal, and external partners to support successful regulatory outcomes.
Lead and manage interactions with U.S. regulatory authorities, consultants, CROs, and other stakeholders.
Establish and maintain effective working relationships to support submission success and issue resolution.
Quality, Risk, and Financial Oversight
Ensure robust quality oversight of regulatory submissions and documentation.
Identify regulatory and operational risks, proactively implementing mitigation strategies.
Provide input into departmental budgeting and resource planning to ensure efficient utilization of regulatory expertise.
Required Skills and Competencies
Demonstrated leadership experience managing high-performing regulatory affairs teams.
Strong strategic thinking and problem-solving skills with the ability to address complex regulatory challenges.
Excellent written and verbal communication skills, including experience interfacing with regulatory authorities.
Proven project management capabilities with the ability to manage multiple priorities in a fast-paced environment.
Education and Experience Requirements
Bachelor’s degree in a scientific or life sciences discipline; advanced degree preferred.
Minimum of 7 years of progressive experience in regulatory affairs within the pharmaceutical or life sciences industry.
Extensive hands-on experience with U.S. FDA regulations, submission pathways, and regulatory strategy development.
Proven track record of successful regulatory submissions, approvals, and lifecycle management activities.
Why Join ProPharma
ProPharma is committed to building a diverse, inclusive, and collaborative workplace where employees are empowered to grow professionally and contribute meaningfully to patient health worldwide. All applications are personally reviewed by experienced recruitment professionals, and every candidate receives clear feedback on their application status. Remote working is supported, with hybrid collaboration encouraged where feasible.
Equal Opportunity Statement
ProPharma is an Equal Opportunity Employer and values diversity, equity, and inclusion. Employment decisions are made without regard to legally protected characteristics.
Note: ProPharma Group does not accept unsolicited resumes from recruiters or third-party agencies.
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