(Senior) Project Manager - Regulatory Compliance

When our values align, there's no limit to what we can achieve.

At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Purpose:

The Senior Regulatory Project Manager leads APAC and ex-APAC compliance projects as part of Parexel 's Strategic Compliance Consulting Global Operation team. Acting as a Project Lead (PL), this role collaborates with Parexel Project Technical Leads (TL) and Subject Matter Experts to manage project timelines, resources, and stakeholder alignment while ensuring adherence to Parexel 's quality standards, effective budget management, fiscal responsibility, and timely project delivery. This highly visible, cross-functional role requires strong project leadership, agility, and strategic foresight to support the mission of bringing quality drug products to patients worldwide.

General areas of responsibility include: client liaison and relationship management, project assessment and initiation, resource planning and identification, project implementation scheduling, leading and motivating cross-functional teams, milestone planning and forecasting, ensuring projects progress according to contract and quality standards, producing key project progress reports, managing communication and financial oversight between the Parexel project team and clients, aligning cross-functional stakeholders to manage complex timelines, anticipating challenges, and enabling successful delivery of project milestones.
Key Accountabilities:

Project Initiation Management

- Ensure tools are set-up according to SOP’s and work instructions, e.g., Project management Plan, SOP’s list, Workday Codes list, team list, project specific trainings management in LMS.

- Cooperate with the Finance Business Partner (FBP) to ensure that any systems and system interfaces are functioning and are ready for use by the project teams.

- Work as PL with TL to provide initial schedule and resource plan to Compliance senior management team.

- May also own the client relationship and responsibility for client communication ensuring high client satisfaction.

- Proactive approach to providing solution set for clients.

Project Execution Management

- Schedule client kick-off-meeting and discussions with client, by establishing client expectations for project delivery, communication, and client specific metrics. Ensure the scope of the project is well understood by the project team and set the team expectations.

- Review the project contract exhibit and ensure relevant team members have received budgeted hours.

- Manage the Onboarding Guideline of the project team, oversee request for resources, review proposed team members for suitability and manage any project team changes throughout the duration of the project.

- Work with the Project Specialist (PS), on developing a project plan and tools including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, Project Plan, Communication Plan, Risk Analysis, etc).

- Review initial budget request to FBP/CS for any project specific adaptations.

- Review and finalize project metrics with FBP and TL/PS.

- Participate in or manage the team kick-off meeting, ensure the scope of the project is well understood by the project team and that the appropriate resourcing has been assigned.

- Work with the TL to set up project-related training as needed for team members.

- Schedule the Lessons Learned / Opportunities meeting with Consulting Lead to ensure client’s needs are well met.

Project Implementation, Control & Evaluation