Manager, Regulatory Operations at Advanced Recruiting Partners Manager, Regulatory Operations at Advanced Recruiting Partners in Raleigh, North Carolina Posted in 3 days ago.

Type:

full-time

Job Description:

The Manager - Regulatory Operations provides leadership, supervision, and line management for the Regulatory Start-Up team. The role ensures staff are appropriately trained and supported in the execution of clinical trial regulatory start-up activities, including Regulatory Authority (RA) and Ethics Committee (EC) submissions and approvals, site identification, and regulatory intelligence. Responsibilities are carried out in accordance with: ICH-GCP guidelines Local regulatory requirements Company and client Standard Operating Procedures (SOPs) Project Agreements The Manager is responsible for team leadership, operational oversight, staff development, and ensuring timely and high-quality regulatory start-up deliverables. Minimum Qualifications Education Bachelor's degree in Clinical Sciences, Pharmacy, Life Sciences, or a related discipline; or Equivalent pharmaceutical industry experience with demonstrated leadership responsibilities. Experience Minimum of 7 years of experience within the pharmaceutical, biotechnology, or CRO industry. Strong experience in clinical trial regulatory affairs and study start-up activities. Demonstrated project management experience. Previous line management and/or matrix management experience. CRO experience strongly preferred. Key Responsibilities Leadership & People Management Lead, mentor, and manage members of the Regulatory Start-Up team. Oversee onboarding and ensure completion of company induction requirements. Ensure staff understand and comply with company policies, procedures, and regulatory requirements. Conduct regular one-on-one meetings to review workload, performance, career development, and employee well-being. Establish performance goals and conduct probationary and annual performance evaluations. Develop succession plans and support employee career progression. Monitor staff performance and provide coaching and feedback. Approve leave requests, expense reports, and timesheets. Collaborate with Human Resources and department leadership on recruitment and workforce planning. Participate in interviewing and hiring new employees. Partner with Learning & Development to identify training needs and support staff development. Contribute to departmental meetings, process improvements, and development of Regulatory Start-Up SOPs. Monitor team utilization and resource allocation. Project Execution & Regulatory Start-Up Provide oversight for the planning, preparation, review, and submission of Regulatory Authority (RA) and Ethics Committee (EC) applications to support timely clinical trial approvals. Review investigational product packaging and labeling documentation. Prepare, review, and submit import/export permits and licenses for investigational products. Review and approve essential clinical trial documents, including: Participant Information Sheets (PIS) Informed Consent Forms (ICFs) Review Regulatory Green Light packages supporting investigational product release. Develop and maintain project tracking tools to monitor milestones, timelines, and performance metrics. Participate in project team meetings and provide regulatory start-up expertise. Represent Regulatory Start-Up during client meetings and contribute to study start-up strategies and timelines. Serve as a local regulatory expert, providing guidance on clinical trial regulations, ethics submissions, approvals, and regulatory intelligence. Establish and maintain relationships with external vendors supporting study start-up activities, including: Central laboratories Drug depots Couriers Regulatory consultants Translation vendors Operational Excellence Ensure compliance with company policies, SOPs, and applicable regulatory requirements. Identify opportunities for process improvement and operational efficiencies. Support the development and revision of departmental SOPs and guidance documents. Participate in company initiatives related to Regulatory Start-Up operations. Maintain a high standard of professionalism in all interactions with clients, investigators, vendors, and internal stakeholders. Business Development Support Monitor local clinical trial regulations and industry developments. Advise Operations and Business Development teams regarding country-specific regulatory requirements. Identify opportunities to expand services within existing client projects. Provide regulatory strategy guidance during proposal development and bid defense meetings. Oversee external contractors performing regulatory registration or marketing support activities. Represent the organization at industry conferences and professional meetings. Site Identification & Feasibility Lead strategic site identification activities to support successful clinical trial start-up. Manage site identification specialists and provide leadership for feasibility assessments. Evaluate potential investigational sites based on protocol requirements, patient population, regulatory considerations, and operational feasibility. Collaborate with Project Management to define site selection criteria. Review clinical protocols and regulatory guidance to support effective site selection. Maintain site intelligence databases and country-specific site information. Collaborate with Clinical Operations, Project Management, Quality Assurance, and Country Leadership to collect and maintain site intelligence. Oversee confidentiality processes to ensure appropriate agreements are in place before study discussions. Drive continuous improvement initiatives to enhance the quality, efficiency, and effectiveness of site identification and feasibility activities.