Program Manager - Regulatory

Role Summary

Program Manager - Regulatory. The project manager will assist in the planning and execution of various product developmental programs from pre-clinical through commercialization with a specialization of regulatory operations (Phase 1-3) while adhering to schedule, scope, and budget requirements.

Responsibilities

• The successful candidate will work alongside the team to translate regulatory strategy into project plans. Creating project charts, considering key strategic assumptions and cross-functional dependencies by working closely with the regulatory department.
• Coordinate functional project teams and take full accountability of completion of deliverables, balancing quality and timeliness.
• Analyze, plan, and track project activities overall and on regular basis; pro-actively identify and resolve operational problems and minimize delays along with cross-functional teams
• Track critical path tasks while identifying project risks during the various stages of drug development in regulatory affairs and communicate risks to relevant stakeholders
• Work with external vendors/partners to track project timelines and monitor KPIs as appropriate.
• Track budgetary items, identify resource
• Ensure fluid project communication and report project status to project and program leadership on regular basis.
• Implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management.
• Work with functional leaders to ensure positive team spirit and high functioning team.
• Prepare monthly progress reports and ad hoc reports as required.
• Participates in development of Project Management tools, templates and processes.
• Track spending verses budget projections and identify resource needs.
• Additional tasks and projects as needed and requested.
• Expected to be flexible and uphold the Ocugen value system especially demonstrating the urgency and work towards to complete the activities on time every time.

Qualifications

• Bachelor‚Äôs degree in a science discipline or related field is required. M.S. or Ph.D. degrees desirable.
• Minimum 6 years of pharmaceutical industry experience, with 5 years managing project teams which are 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 and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution
• PMP certification preferred
• Advanced working knowledge of MS Project, OnePager Pro, Excel, OneNote, and PowerPoint
• High level of personal integrity and strong conflict resolution and consensus building skills
• Ability to work effectively with cross-functional teams

Working conditions

Incumbent will primarily work Monday – Friday during normal business hours in an office environment. Travel up to 10% may be required.

Physical Requirements

This is a largely sedentary role.

Direct reports

None