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Ocugen · 3 weeks ago

Program Manager - Regulatory

Main Corporate Office - Malvern, PA 19355

Full-time

Onsite

Senior Level

6+ years exp

Ocugen is a company focused on developing innovative therapies. They are seeking a Program Manager to assist in the planning and execution of product developmental programs, particularly in regulatory operations from pre-clinical through commercialization.

BiopharmaBiotechnologyHealth Care

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

Qualification

Pharmaceutical industry experienceRegulatory operations knowledgeProject management toolsPMP certificationMS Project proficiencyPersonal integrityCross-functional teamworkConflict resolution skills

Required

Bachelor's degree in a science discipline or related field is required

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

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