Senior Manager, Regulatory Affairs Project Management

We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities. This role will be a key member of the team supporting regulatory activities and regulatory execution for clinical trials across the portfolio.  In collaboration with the Regulatory team, you will drive global submission planning and coordination across multiple regions, ensuring alignment with Regulatory, Global Development, and Technical Operations objectives.  The ideal candidate is a proactive, detail-oriented project manager with global regulatory experience who thrives in a face-paced, collaborative biotech environment.

Reporting to the Director of Program management, you will also work closely with other project and program managers within the Program Management Office (PMO) implementing robust PM processes and building effective tools and systems. You’ll support optimization of Regulatory project plans, schedules, stakeholder communications, and Smartsheet operations. The role involves developing and managing high-visibility regulatory submission plans, monitoring milestones, managing documentation, and contributing to regulatory strategy.

Key Responsibilities

• This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions
• Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts
• Work with the Regulatory team to translate strategic regulatory vision into actionable project plans, ensuring all cross-functional activities are coordinated and delivered on time
• Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide
• Monitor CTA/IND submission status across assigned projects
• Support strategic planning and risk mitigation efforts related to regulatory activities, including portfolio level analyses that identify resource bottle necks across all programs and studies
• Support evaluation, implementation, and use of project management tools (especially Smartsheet); define methodologies and reporting frameworks
• Design and maintain Smartsheet sheets, reports, dashboards, and forms related to regulatory activities and ensure integration with program plans
• Troubleshoot and enhance PMO solutions, support system updates and new capabilities
• Demonstrate critical thinking and initiative to improve PM practices

Ideal Candidate

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field
• 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred
• Experience with planning IND/CTA regulatory submissions required
• Familiarity with components of regulatory submissions is required
• Experience planning BLA/NDA/MAA submissions is required
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications
• Experience supporting global interventional clinical studies and CTA submissions
• Hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable
• Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro). Familiarity with regulatory systems (Veeva RIM) preferred
• Knowledge of biotech processes, scientific terminology, drug development concepts
• Proactive and structured approach to problem-solving, with ability to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions
• Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and meet deadlines
• Ability to work independently and thrive in a dynamic environment
• Team player that contributes valuable ideas and feedback and can be counted on to meet commitments
• Position requires up to 20% travel; this includes mandatory in person attendance to company All-Hands meetings held twice a year, additional travel may be required to attend key meetings, typically held at the Apogee San Francisco or Boston offices

The anticipated salary range for candidates for this role will be $150,000-$170,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.