Project Manager Global Regulatory Affairs

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Role Details:

Global Regulatory Affairs (GRA) is responsible for ensuring the quality of documents and submissions to regulatory authorities globally in support of both investigational and marketed product activities. GRA is part of the Consulting group of Fortrea.

GRA is also responsible for authoring medical & regulatory documents and providing strategic input for projects as required.

This position is responsible for the timely preparation/co-ordination of regulatory affairs activities for a particular project and must work to high standards (governmental, Sponsor/Client, Fortrea and self) with minimal supervision. It is the responsibility of this position to ensure that all GRA deliverables for a project are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research. As a Project Manager, you will be accountable for communicating updates and issues to the team members as well as meeting the established timelines.

In this position, you will communicate daily with Regulatory Strategists, Medical Writers, invoicing and will serve as the main contact point to the client.

Responsibilities typically include developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. This position is focused on Regulatory Authority meetings and other pre-marketing authorization communication/documentation (e.g. Pediatric Plans, Orphan Drug Designation, Scientific Advice meetings, Pre-IND meetings, IND compilation, and End of Phase meetings), but you may benefit having both clinical trial regulatory affairs (CTA/IND submission) and post marketing authorization regulatory affairs experience.

This is a permanent, full-time, and home-based (you can also choose to work from the office) position. Depending on your seniority level, this role may be offered at Project Manager or Associate Project Manager level.

Summary of Responsibilities:

• Evaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within project timelines
• Manage the preparation of high-quality responses to RFP/RFI
• Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
• Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirements
• Propose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projects
• Prepare and actively participate as operational lead in internal Project Review meetings
• Present at external and/or internal meetings
• Define and manage project resource needs and establish succession plans for key resources
• Create required project plans
• Implement and monitor progress against project plans and revise as necessary
• Serve as key client contact for assigned project(s)
• Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
• Prepare and deliver presentations in collaboration with relevant departments for new business as required
• Meet financial performance targets for assigned project(s)
• Manage client project metrics
• Perform other duties as assigned by management