Manager, Project Manager Regulatory Affairs
The Regulatory Project Manager (RegPM) provides extensive support to Labcorp Drug Development's clinical studies, projects, and programs where knowledge of and insight to global health authority processes and procedures (eg, meetings, programs, submissions) are required. RegPMs are involved in the full project lifecycle, including proposal development, project planning and management, financial management, cross-functional/divisional coordination, and process improvements. RegPMs will also provide support for key internal initiatives and programs that can benefit from project or program management support.
RegPMs support multiple projects at a time, regularly interact and communicate with client staff (including senior client staff) as the client's main point of contact, and must work to high standards with minimal supervision. RegPMs work with a variety of global clients, generally virtual or small to mid-sized companies, across all asset types (drug, biologic, cell/gene therapy), and across all therapeutic areas. The position can be either office-based where available or remote.
- 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.
- Create required project plans. Implement and monitor progress against project plans and revise as necessary.
- Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.
- Manage client project metrics.
- Define and manage project resource needs and establish succession plans for key resources.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Meet financial performance targets for assigned project(s).
- Manage the preparation of high quality submissions (or parts of submissions) to regulatory authorities for clinical trial, marketing approval, and agency procedures within project timelines.
- Resolve conflicts as needed.
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Labcorp Drug Development and client requirements.
- Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs.
- Prepare and actively participate as operational lead in internal project review meetings.
- Provide performance feedback of team members to respective supervisors.
- Manage the preparation of high quality responses to RFP/RFI
- Prepare and deliver presentations in collaboration with relevant departments for new business as required.
- Evaluate the impact of clinical/regulatory changes on assigned projects as well as Labcorp Drug Development business operations.
Propose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Present at external and/or internal meetings.
Perform other duties as assigned by management.Education/Qualifications:
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulation.
- Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
- Working knowledge of project management processes, especially as it relates to clinical development.
- Working knowledge of time and cost estimate development.
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Excellent communication skills, organization and planning skills and attention to detail.
- At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development.
- Demonstrated skills and competency in project management tasks and ability to work independently.
- Experience in managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Good computer skills with good working knowledge of a range of computer programs.
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