Program Manager - Regulatory

Program Manager - Regulatory

Description

Job Purpose

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.

Duties and 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 a regular basis; proactively 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 needs.
• Ensure fluid project communication and report project status to project and program leadership on a 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.
• Participate in the development of Project Management tools, templates, and processes.
• Track spending versus 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 working towards completing activities on time every time.

Qualifications

• Bachelor’s degree in a science discipline or related field is required. M.S. or Ph.D. degrees desirable.
• Minimum 5 years of pharmaceutical industry experience, with at least 2 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 of 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