Manager, Regulatory Operations

Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field. Advanced degree preferred. Minimum 10+ years of experience in regulatory operations publishing in biotech or pharma. Expertise in software tools and processes used in regulatory submissions; adept at integrating different systems and adapting to client-specific software. Expertise in formatting and publishing tools, adept at utilizing Adobe and Microsoft Office add-ins. Strong attention to detail crucial for error-free document preparation and validation. Effective communication skills, both verbal and written, essential for team collaboration and client interactions. Flexible and able to adapt to handle regulatory updates and varying project demands. Broad software proficiency; strong knowledge of MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, eCTD Publishing Software, and Electronic Document Management Systems.

Manage systematic submissions for regulatory documents, ensuring compliance with FDA guidelines. Conduct client meetings to update on responsibilities and project status. Independently coordinate components of regulatory submissions. Handle multiple client projects simultaneously, addressing unplanned submissions and urgent FDA requests. Format documents to meet FDA electronic submission standards and conduct quality control checks. Maintain responsibility for the planning, timelines and production of large complex FDA submissions. Conduct and/or participate in final review of published submissions to ensure compliance to requirements. Lead the regulatory operations team, ensuring client-facing roles align with business goals. Communicate Leadership Team decisions, initiatives, and activities to Managers, Regulatory Operations. Understand, interpret and consult on regulatory eCTD submissions. Train/coach team members in submission publishing techniques and processes. Provide mentorship and management to team members. Maintain a calm demeanor under pressure, leveraging deep knowledge of international regulatory requirements. Emphasis on teamwork, collaboration, and enhancing project coordination and communication. Resource allocation across team including routine meetings, development and recruiting needs.