Regulatory Affairs Project Manager: Cross‑Functional Lead

Enigma Search; South San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Enigma Search is seeking a Project Manager, Regulatory Affairs to bring structure, visibility, and execution excellence to our growing regulatory team in the biopharmaceutical space. You will manage regulatory planning, timelines, and cross‑functional coordination across development programs, ensuring health authority interactions, medical writing deliverables, and submissions stay on track.

The role requires strong experience in regulatory project management within biotech, a science-based

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.

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.

Skills

Regulatory Affairs

Project management

Biopharmaceutical knowledge

Cross-functional collaboration

Education

Bachelor's degree in science or related field

Advanced degree preferred

Job description

Enigma Search is seeking a Project Manager, Regulatory Affairs to bring structure, visibility, and execution excellence to our growing regulatory team in the biopharmaceutical space. You will manage regulatory planning, timelines, and cross‑functional coordination across development programs, ensuring health authority interactions, medical writing deliverables, and submissions stay on track.

The role requires strong experience in regulatory project management within biotech, a science-based