Program Manager - Regulatory

Role Summary

Program Manager - Regulatory will support planning and execution of regulatory-focused product development programs from pre-clinical through commercialization, specializing in regulatory operations (Phase 1–3), while ensuring adherence to schedule, scope, and budget. The role involves coordinating cross-functional teams and external partners to translate regulatory strategy into actionable project plans.

Responsibilities

• Translate regulatory strategy into project plans; create project charts and assess key strategic assumptions and cross-functional dependencies in collaboration with the regulatory department.
• Coordinate functional project teams and ensure completion of deliverables with quality and timeliness.
• Analyze, plan, and track project activities; proactively identify and resolve operational problems to minimize delays with cross-functional teams.
• Track critical path tasks and identify project risks across regulatory drug development; communicate risks to relevant stakeholders.
• Work with external vendors/partners to track timelines and monitor KPIs as appropriate.
• Track budgetary items and identify resource needs.
• Ensure fluid project communication and report project status to project and program leadership on a regular basis.
• Implement best practices across project teams (resource capacity planning, risk management, team performance, timeline development, portfolio management).
• Collaborate with functional leaders to maintain a positive team environment and high-functioning teams.
• Prepare monthly progress reports and ad hoc reports as required.
• Contribute to the development of project management tools, templates, and processes.
• Track spending versus budget projections and identify resource needs.
• Perform additional tasks and projects as needed and requested.
• Maintain flexibility and uphold company values, with urgency to complete activities on time.

Qualifications

• Minimum 6 years of pharmaceutical industry experience, with 5 years managing project teams in the regulatory phase.
• Experience of working as part of a multi-functional team and supporting regulatory activities from discovery through commercialization.
• Possesses knowledge of all phases regulatory exposure throughout the drug development cycle.
• Knowledgeable in PM processes and can competently use essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution.
• PMP certification preferred.
• High level of personal integrity and strong conflict resolution and consensus-building skills.
• Ability to work effectively with cross-functional teams.

Skills

• Proficiency with MS Project, OnePager Pro, Excel, OneNote, and PowerPoint.
• Strong communication, problem solving, and collaboration skills.
• Ability to translate regulatory strategy into actionable plans and to manage cross-functional project teams.

Education

• Bachelor’s degree in a science discipline or related field required; MS or Ph.D. degrees desirable.

Additional Requirements

• Travel up to 10% may be required.
• This is a largely sedentary role.