The Regulatory Submissions PM drives multiple, major NDA submission efforts and programs with limited direction and oversight. The Project Manager acts as a central contact for information on a particular program and manages activities to develop programs, ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. The PM works with management staff and team members to create the submissions development strategy, establish objectives, and monitor plan/team progress. The PM makes recommendations regarding project objectives, resource requirements, and scientific direction to team and senior management.
- Provides regulatory project management and support for pre-clinical and clinical areas for investigational and marketed products.
- Applies NDA and/or eCTD submission experience to the development and oversight of the strategic implementations of electronic regulatory submissions processes and systems.
- Supports cross-functional compound-level project teams toward implementation of the strategic and operational submission plans and tracks progress to goals.
- Assures that Regulatory Affairs is adequately represented on project teams for assigned products.
- Is responsible for maintenance of the project actions, risks, decisions, and issues.
- Maintains regulatory submission and project schedules using Microsoft Project.
- Facilitates the review of projects with Senior Management, makes recommendations for action and ensures appropriate follow-up by management to achieve approved objectives.
- Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions.
- Is responsible for ensuring smooth transitions between action points.
- Supports quarterly forecasts, manages scopes, timeline and financial changes through tracking variances at the program level.
- Works with relevant areas/teams to lead the development of strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions).
- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at the project and program level, timeline issues, and budget issues. Works proactively with manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives.
- Is responsible for ensuring timely, accurate and comprehensive project and program information is available to senior management and the wider organization.
- Bachelor’s degree in science or relevant field
- At least 5 years of pharma experience
- Project management skills
- Experience and knowledge to assist teams and prepare for regulatory interactions; NDA/eCTD submission experience highly valued
- Experience and sound working knowledge of the drug development process
- Fluency with Microsoft Project
- MBA or graduate-level degree desirable
- PMP certification desirable
- Exceptional verbal and written communication skills with high level of attention to detail
Pharmica thanks you for your interest in this position. Please note that only qualified candidates will be contacted.