Project Manager - Regulatory

Initial Therapeutics, Inc.; Malvern (Chester County); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a skilled Project Manager to lead product development programs from pre-clinical stages through commercialization. This role emphasizes regulatory operations, requiring expertise in project management and collaboration with cross-functional teams. The successful candidate will be responsible for creating project plans, managing risks, and ensuring timely delivery of project milestones. You will thrive in a dynamic environment, implementing best practices and fostering a high-functioning team spirit. If you are passionate about driving innovative projects in the pharmaceutical sector, this opportunity is perfect for you.

Qualifications

• 5+ years in the pharmaceutical industry with regulatory project management experience.
• PMP certification preferred, with strong knowledge of PM processes.

Responsibilities

• Manage project plans and timelines, ensuring adherence to budget and scope.
• Coordinate cross-functional teams and track project activities proactively.

Skills

Project Management

Regulatory Affairs

Conflict Resolution

Cross-Functional Team Collaboration

Budget Management

Education

Bachelor’s degree in Science

M.S. or Ph.D. in related field

Tools

MS Project

OnePager Pro

Excel

OneNote

PowerPoint

Job 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; 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 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 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 that are in the regulatory phase.
• Experience 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

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.