Manager, Regulatory Affairs, Operations

Required

• Strong understanding of Regulatory Operations business processes and the functional document types that comprise global regulatory submissions, including clinical, nonclinical, quality, labeling, and administrative content
• Working knowledge of RIM data models and processes, including regulatory activities, applications, submissions, registrations, commitments, correspondence, document metadata, and reporting
• Excellent written and verbal communication skills, including the ability to train users, facilitate discussions, and influence without direct authority
• Demonstrated project management, organization, prioritization, and problem-solving skills in a deadline-driven environment with changing priorities
• High attention to detail, sound judgment, accountability, integrity, and a strong commitment to quality and compliance
• Ability to work independently with moderate guidance while collaborating effectively across functions and with external partners
• Proficiency with Microsoft Office applications and PDF tools; experience with regulatory publishing and RIM platforms is preferred
• Willingness and ability to travel domestically and internationally as needed
• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%