Senior Manager, Regulatory Affairs Project Management
Job Description:
- 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
Requirements:
- 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 and frequent trips to Apogee offices in San Francisco and/or Boston
Benefits:
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team, in-person meetings to build relationships and problem solve
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