Manager of Clinical and Regulatory Affairs
About The Position
The Manager of Clinical and Regulatory Affairs owns the clinical and regulatory strategy for Pangea’s diagnostic portfolio, including prioritization, sequencing, and execution of clinical programs and regulatory submissions. This role focuses primarily on clinical trials and submissions to enable regulatory authorization (IVDR and FDA) and market access for Bladder CARE, while also supporting emerging initiatives in NGS-based microbiome diagnostics. This position is ideal for a highly motivated professional who can operate strategically and tactically within a lean team environment. The director will be expected to manage and execute programs efficiently with limited resources, collaborating closely with the Chief Scientific Officer and a Clinical Trial Project Manager.
Requirements
- Bachelor’s or Master’s degree in life sciences, biomedical sciences, public health, or related field
- 4–7 years of experience in clinical affairs, clinical research, or clinical operations within diagnostics, medical devices, biotechnology, or laboratory testing
- Experience supporting clinical studies, including site/vendor coordination, data tracking, and study execution
- Strong project management skills with ability to manage multiple studies and timelines simultaneously
- Experience working with CROs, investigators, or external clinical partners
- Familiarity with GCP and general clinical research standards
- Strong organizational, communication, and problem-solving skills
Nice To Haves
- Experience in molecular diagnostics, oncology, urology, or laboratory-developed tests (LDTs)
- Experience supporting clinical utility or observational studies
- Exposure to regulatory processes for IVD or CE-IVD / IVDR (direct ownership not required)
- Experience supporting publications, abstracts, or scientific presentations
- Experience in a small or early-stage company environment
Responsibilities
- Support the planning and execution of clinical studies for Bladder CARE, including clinical utility and evidence generation initiatives
- Coordinate study activities with external partners, including investigators, clinical sites, CROs, and vendors
- Assist in development and refinement of study documents, including protocols, case report forms, and study plans
- Track study timelines, milestones, budgets, and deliverables to ensure on-time execution
- Monitor study progress and identify risks or delays, escalating as needed
- Support data collection, data quality review, and coordination with biostatistics or external partners
- Contribute to preparation of abstracts, manuscripts, and scientific presentations
- Support development of evidence packages used for physician education, publications, and payer discussions
- Maintain organized documentation to support study execution and audit readiness
- Support CE-IVD / IVDR-related activities by coordinating with external regulatory consultants and internal teams
- Assist in compiling documentation and tracking deliverables required for regulatory submissions
- Maintain regulatory documentation, trackers, and internal files
- Coordinate cross-functional inputs (lab, quality, clinical) required for regulatory activities
- Monitor timelines and ensure alignment with project milestones
- Provide clinical, scientific and regulatory input to product development teams and senior leadership.
- Work closely with laboratory operations, R&D, commercial, and leadership teams
- Coordinate with external consultants (clinical, regulatory, statistical) as needed
- Support communication of study progress and key updates to internal stakeholders
- Contribute to a collaborative, execution-focused environment in a growing organization
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1-10 employees
