Vice President | Head of Regulatory Compliance

Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client conducts outpatient clinical trials across a network of seven (7) owned clinical trial sites in California, Nevada and Texas. They enroll patients in general medicine clinical trials across multiple therapeutic areas (“TA”) including gastroenterology, neurology, obesity, pain, vaccines and women’s health with the support of its 20+ principal investigators and sub-investigators.

Key Responsibilities

• Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies to ensure compliance with all applicable laws and regulations governing clinical research activities.
• Policy and Procedure Oversight: Oversee the creation, implementation, and maintenance of regulatory policies and procedures to ensure they are up-to-date and in line with current regulations.
• Compliance Monitoring: Establish and maintain systems for monitoring compliance with regulatory requirements, including regular audits and inspections of clinical research sites.
• Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively.
• Training and Development: Lead the development and delivery of training programs for staff on regulatory compliance topics to ensure a high level of understanding and adherence to regulatory requirements.
• Stakeholder Engagement: Serve as the primary point of contact for regulatory agencies and other external stakeholders, ensuring effective communication and collaboration.
• Regulatory Submissions: Oversee the preparation and submission of regulatory documents, including clinical trial applications, amendments, and annual reports.
• Performance Metrics: Develop and track key performance indicators (KPIs) to measure the effectiveness of the regulatory compliance program and identify areas for improvement.
• Quality Control: Implement and maintain quality control measures to ensure the integrity and reliability of clinical research data. This includes establishing quality assurance processes, conducting regular audits, and ensuring that all research activities meet the highest standards of quality and compliance.

Key Requirements

• Educational Background: Advanced degree in a relevant field such as regulatory affairs, clinical research, or a related discipline.
• Experience: Minimum of 10 years of experience in regulatory compliance within the clinical research industry, with at least 5 years in a leadership role.
• Knowledge: In-depth knowledge of regulatory requirements and guidelines governing clinical research, including FDA, EMA, and ICH regulations.
• Leadership Skills: Proven ability to lead and manage a team, with strong interpersonal and communication skills.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to assess complex regulatory issues and develop effective solutions.
• Attention to Detail: High level of attention to detail and accuracy in regulatory documentation and reporting.
• Project Management: Excellent project management skills, with the ability to manage multiple projects and priorities simultaneously.
• Adaptability: Ability to adapt to changing regulatory environments and stay current with industry trends and developments.

Location: Location: TX, CA, AZ, Nevada

Location(s)

If interested, please send a MS Word version of your resume to [email protected]

Submit Your Résumé