Regulatory Operations Jobs in Raleigh, NC (NOW HIRING)

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.