North AmericaFull TimeOperations
Remotely
project managementagileregulatory affairspharmaceuticalregulatory submissionscross functionalhealth authority
Job Description
📋 Description
- Translate regulatory strategy into actionable project plans, milestones, deliverables, timelines
- Lead planning and execution of complex regulatory projects and submissions end-to-end from
- Create and update critical paths for regulatory submissions with internal/external dependencies and
- Track and report project performance metrics: milestones, timelines, resourcing, documentation
- Coordinate Submission Deliverable Teams and Regulatory Excellence Team activities across
- Hold project team members accountable to plans, organizing follow-ups and ensuring resources are
🎯 Requirements
- Bachelor's degree in life sciences, pharmacy, chemistry, or Business Administration.
- At least 5 years of progressive experience in pharmaceutical/biotech, preferably in project
- Significant experience managing complex projects, cross-functional teams, timelines, dependencies
- Experience with project management in pharmaceutical/biotech environments; understanding of
- Knowledge of regulatory processes and therapeutic areas preferred.
- Practical application of project management processes, tools, tracking systems, and databases.
🎁 Benefits
- Base salary typically ranging from $140,000 to $222,000, depending on qualifications and experience.
- Potential eligibility for role-specific variable or performance-based bonus and other compensation
- Opportunity to lead high-impact regulatory projects in pharma/biotech.
- Exposure to global regulatory affairs and cross-functional development programs.
- Collaborative environment with regulatory leaders and specialized functions.
- Opportunities to contribute to operational excellence and Agile transformation.