Senior Manager, Regulatory

March 29

Care Access

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A new vision for healthcare. Where clinical research is a patient care option.

rare diseases • pulmonology • oncology • decentralized • decentralized trials

201 - 500

Description

• Lead the Regulatory department to support all assigned individuals within the team • Provide oversight and work proactively with the Care Access team to solve regulatory issues • Develop, implement, and maintain robust North American regulatory strategies • Lead a team of regulatory professionals, providing guidance and training • Collaborate with cross-functional teams to ensure regulatory compliance • Build relationships with external partners to support the Regulatory team and company • Drive continuous improvement initiatives in regulatory processes and systems • Maintain knowledge of pertinent regulations and guidance • Ensure quality is maintained in all investigator site files and regulatory workflows • Provide back-up support to Regulatory Specialist role as needed • Manage study caseload & ISF • Support the submission of new CLIA waiver applications and maintain CLIA certification • Lead by example and display a high level of integrity and professionalism

Requirements

• Bachelor’s Degree required in life sciences or equivalent education • 7+ years of experience in regulatory affairs within the clinical research industry • Expert knowledge of federal research regulations and good clinical practices • Strong knowledge of US and Canadian regulations governing clinical trials • Demonstrated leadership skills with experience managing a team • Excellent communication, organizational, and problem-solving skills • Strong computer skills with demonstrated abilities using clinical trials database systems • Ability to prioritize and handle multiple projects simultaneously • Strong self-motivation, energy, initiative, and flexibility • CCRC or CCRP certification preferred

Benefits

• Competitive salary • Health insurance • Retirement plan • Paid time off • Professional development opportunities