Regulatory Manager

Put your talents to work at PCM Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career Responsible and accountable for managing, the regulatory affairs function within EmVenio Research, in the areas of regulatory submissions, documentation, education, training and compliance, including the use of Good Clinical Practice principles with understanding and application of Food and Drug Administration regulations and International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines. The regulatory role ensures smooth coordination of research activities with clinical research staff, sponsors, CROs, IRBs, and other internal stakeholders. This position provides regulatory oversight, organization, and coordination of research involving physicians and clinicians, as well as other involved departments. The ideal candidate will possess strong written and verbal communication skills, attention to detail, ability to meet multiple changing deadlines, and the ability to work independently. This position will be remote. QUALIFICATIONS Bachelor’s Degree in healthcare or science-related field Minimum of 2 year’s experience in leading a regulatory department within a clinical research site, site network, SMO or IRO and liaising with IRB’s & Sponsors. Strong proficiency in Microsoft Office programs (Outlook, Word, Excel, Adobe) and web applications ICH-GCP Certification Knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH, GCP guidelines are preferred. Supervisor experience preferred Ability to plan, organize, set priorities, and work in a fast-paced environment and handle multiple projects simultaneously and efficiently with precision. Ability to Create and maintain controls on documents. Ability to use software to develop organized information sources and to provide a variety of reports. Must possess excellent verbal and written communication skills. Ability to work well independently as well as with co-workers, peers, supervisors, and external sources. Ability to adapt to changes in responsibilities and workloads. Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic. Must possess a high degree of integrity and ability to maintain confidentiality with Protected Health Information (PHI) guidelines, subject matters, and other confidential information. Demonstrated capacity to problem solve, think critically and creatively, and provide support through a consultative role. Ability to communicate effectively when reading and writing e‑mail, letters, and other reports. ESSENTIAL FUNCTIONS/AREAS OF ACCOUNTABILITY Updates Clinical Trials Management Systems (CTMS) as needed with essential profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information. Prepares regulatory documentation packets and creates all FDA 1572 Forms for IND filings. Distributes financial disclosure forms, protocol signature pages, and FDA 1572 forms to obtain investigator and staff signatures. Assists with the completion of signature logs, training logs, and all regulatory documents. Ensures all necessary forms are submitted to the Sponsor company to activate protocols. Maintains regulatory ‘binders’ both in the CTMS and physical where mandated by a sponsor Posts regulatory documents including but not limited to protocols, amendments, consent forms, SAE forms, etc. in the CTMS. Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly. Prepares, maintains, updates, and audits study‑specific regulatory files, IRB files per FDA guidelines and resolves queries, as necessary. Distributes IRB documentation and post IRB meeting information to study sponsors, research, and clinical staff accordingly. Communicate effectively with the company’s coordinators, Site managers, Project managers and management teams; pharmaceutical companies; CRO’s; IRBs; study sponsors, and other team members. Advise others on regulatory and compliance matters. Identify and interpret relevant regulatory guidelines. Performs regular reviews on investigator site files to ensure compliance May perform other duties not specifically listed in this job description as assigned by their immediate supervisor. Supervisory Responsibilities: Oversees the daily workflow and compliance of the department staff Recruits, interviews, hires, and trains new staff as needed Provides constructive and timely feedback and performance evaluations. The typical base pay range for this role is USD $87,800 - $131,300 per year. Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors. Available Benefits Include Medical Dental Vision 401(k) Company Paid Short Term Disability Flexible Spending Account (FSA) Health Savings Account (HSA) Paid Time Off Voluntary Benefits Please contact Carson Moreira-Rego at x387 or at today to learn more about our opportunities where you can make a difference in your own career Professional Case Management is an Equal Opportunity Employer. #J-18808-Ljbffr