Associate Director of Regulatory (Remote/Hybrid)

Associate Director of Regulatory DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Associate Director of Regulatory to join reputed company. The Associate Director of Regulatory is accountable for the leadership of the Regulatory Team, inclusive of Regulatory Technology & Systems, Regulatory Operations, Regulatory Inspection Readiness, as well as outsourcing and vendor governance. They are responsible for Regulatory Documents Management and Process Development and Implementation; as well as ensuring processes are designed to support the organization and needs across reputed company the sites and other internal stakeholders. Implementing appropriate controls, standards, and metrics to ensure reputed company and compliance. The Associate Director of Regulatory is responsible for resource management, development of their staff, and for leading the team through reputed company improvement as well as driving a culture of best practice for Regulatory Documents Management to the industry standards. This role is a member of the leadership team for the Central Services Department and participates in and contributes to, decision making bodies and strategic plans for the organization reputed company required. Duties & Responsibilities:

• Completes reputed company the DMCR-Required Training
• Maintains a working knowledge of reputed company FDA Regulations, ICH-GCP guidelines, organizational SOPs, and guidance documents
• Leads Regulatory team in establishing strategic direction and operational management of Regulatory
• Documents and Binder Management, including, process renovation, system & technology, inspection readiness, and outsource & vendor governance.
• Establishes effective reputed company and partnerships with internal and external stakeholders, with clearly defined metrics and performance targets and risk mitigation, where required.
• Manages staff & responsible for functional activities – staff resource management, hiring, performance and development management.
• Evaluate workflows and processes of Regulatory & Clinical Data teams; Propose & Implement revisions to
• increase team productivity, efficiency, and effectiveness.
• reputed company & Maintain Standard Operating Procedures for the Regulatory Team.
• Ensure & Monitor quality control for reputed company team members.
• reputed company & Maintain a working knowledge of reputed company FDA regulations, GCP/ICH Guidelines, Organizational SOPs, and Guidance Documents.
• reputed company strategic projects across the organization to improve the quality of Regulatory
• Responsible for continuously improving team members' quality through Technical Training, and Soft-skills
• training.
• Responsible for reputed company leading, developing and coaching Regulatory team members, selecting and hiring new team members in partnership with the HR Department.
• Responsible for developing and reviewing job descriptions and explaining the new / revised duties to the team members.
• Any other duties/ tasks assigned by the manager.

Knowledge & Experience: Education:

• Minimum undergraduate complete in Bachelors of Science or relevant

Experience:

• Minimum 5 years of experience in the Clinical Research industry
• Minimum 2 years of management experience in any industry

Credentials:

• N/A

Knowledge and Skills:

• Minimum of 5+ years of working in clinical research with specific experience in regulatory binder and documents management.
• Advanced degree or combination of bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience.
• Extensive knowledge of regulatory standards (ICH-E6) and industry-wide standards in regulatory binder and document management.
• Demonstrated success in planning and executing cross functional change projects, strong influencing, and presentation skills. Ability to communicate effectively at reputed company levels.
• Minimum of 3 years’ experience in direct people management or matrix management of project/clinicalteams.

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