Senior Manager, Clinical Regulatory Affairs

For our client, we are seeking a Senior Manager, Clinical Regulatory Affairs to join the team of a leader in the Pharmaceuticals & Biotech space. This role will help shape global clinical regulatory strategies for development programs across U.S., EU, and other international markets. You will partner closely with clinical, development, and operational stakeholders to guide submissions, meetings, and documentation that support timely advancement of programs. The position also plays an important role in identifying regulatory risks, informing study design, and helping ensure alignment with evolving health authority expectations. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $159,800 – $202,650 annually Responsibilities Support development of global clinical regulatory strategies for assigned programs Contribute to regulatory document preparation, review, and submission for clinical trials Partner with cross-functional teams to ensure timely regulatory deliverables Assist in planning for health authority meetings and preparing briefing materials Provide regulatory input into clinical study designs and trial documentation Monitor regulatory requirements and competitive intelligence in relevant fields Support teams in identifying regulatory risks and proposing mitigation strategies Qualifications Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related field required; advanced degree preferred Senior Manager: 6+ years of relevant regulatory affairs experience Associate Director: 8+ years of experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs Strong understanding of clinical regulatory strategies and operations across U.S., EU, and global markets Excellent written and verbal communication skills for preparing regulatory documents and executive summaries Strong project management, organizational, and prioritization skills for managing multiple deliverables Collaborative style with the ability to influence without authority Benefits Competitive Medical, Dental, and Vision plans Access to a 401k plan with a 100% match up to the first 4% deferral Generous Paid Time Off policy Employee commuter benefits Cell phone stipend Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.