The Opportunity
This is an exciting opportunity to bring structure, visibility, and execution excellence to a growing Regulatory Affairs organization. We are dedicated to advancing scientific discoveries into innovative therapies that have a meaningful impact on patients' lives. Our team values collaboration, curiosity, and a shared commitment to improving outcomes for individuals with serious diseases.
As the Project Manager, Regulatory Affairs, you will play a critical role in supporting regulatory planning, timeline management, and cross-functional coordination across development programs. You will help ensure that regulatory activities, health authority interactions, medical writing deliverables, and submission-related workstreams are well organized, on track, and supported by clear accountability.
Working closely with Regulatory Affairs, Medical Writing, and Regulatory Operations teams, you will help implement practical project management processes that drive the timely execution of key regulatory milestones and support ongoing clinical development efforts.
Key Responsibilities
- Maintain integrated plans and timelines for regulatory activities, including health authority interactions, IND amendments, annual reports, key development milestones, and future submission activities.
- Partner with Medical Writing to monitor document development timelines, review cycles, comment resolution, approvals, and readiness for critical clinical and regulatory documents.
- Coordinate cross-functional team members across regulatory, clinical, technical, quality, and external partner organizations to ensure regulatory workstreams progress efficiently.
- Track action items, owners, due dates, dependencies, open issues, decisions, and follow-up activities to maintain organization and accountability.
- Proactively identify schedule risks, bottlenecks, resource constraints, unresolved issues, and readiness concerns, escalating when appropriate.
- Prepare meeting agendas, summaries, dashboards, and status reports that provide clear visibility into priorities, progress, and risks.
- Support the development of practical project management tools, trackers, templates, and processes that improve coordination while minimizing unnecessary administrative burden.
Qualifications
- 5+ years of project management experience within the biopharmaceutical industry, supporting Regulatory Affairs, clinical development, or regulatory submission activities.
- Bachelor's degree in a scientific, healthcare-related, or business field required; advanced degree and/or project management certification preferred.
- Working knowledge of drug development and regulatory processes, including health authority interactions, IND maintenance, and key clinical development milestones.
- Proven experience developing and managing project plans, timelines, trackers, dashboards, meeting materials, and status communications across cross-functional teams; proficiency with project management tools is preferred.
- Strong organizational skills and attention to detail, with the ability to manage actions, dependencies, risks, decisions, and follow-up activities across multiple workstreams.
- Excellent communication and collaboration skills, with the ability to thrive in a hands-on, fast-paced biotech environment while partnering effectively with both internal stakeholders and external collaborators.