The Regulatory Team Lead plays a pivotal role in providing leadership and guidance to the regulatory affairs team, ensuring efficient execution of regulatory strategies and compliance with applicable regulations. This position requires strong regulatory expertise, excellent communication skills, and the ability to mentor and support team members in achieving their goals. The Regulatory Team Lead collaborates closely with the Regulatory Manager to drive continuous improvement and foster a culture of excellence within the Regulatory Affairs Department.
Duties & Responsibilities

• Provide leadership, mentorship, and direction to the regulatory affairs team to enhance regulatory knowledge, skills, and performance
• Assist in developing, implementing, and overseeing regulatory strategies to ensure compliance with DM SOPs, ICH-GCP guidelines, and regulatory requirements
• Collaborate with cross-functional teams to facilitate regulatory activities and serve as a liaison between regulatory affairs and other departments
• Oversee planning, coordination, and execution of regulatory activities, identifying and mitigating risks and issues impacting submissions
• Stay updated on regulatory developments, trends, and best practices, providing recommendations to enhance regulatory processes
• Identify opportunities for process improvement, implement initiatives to enhance efficiency and compliance, and develop and implement quality control measures for regulatory processes
• Ensure adherence to quality standards and procedures, monitor implementation of quality control measures, and conduct audits and assessments to ensure compliance
• Prepare the regulatory affairs team for FDA inspections, sponsor audits, and internal QA audits, ensuring documentation and processes are inspection-ready and facilitating timely and accurate responses to audit findings
• Collaborate with internal QA teams to prepare for audits, ensuring regulatory processes meet internal quality standards, and maintain accurate documentation of regulatory activities, generating reports and metrics to track compliance and performance
• Provide training on regulatory processes and requirements, support professional development of team members, and communicate effectively with internal and external stakeholders, addressing inquiries and providing regulatory guidance as needed
• Monitor regulatory compliance throughout project lifecycles, ensure adherence to regulatory timelines and milestones, identify and assess regulatory risks, develop and implement risk mitigation strategies, and review and approve regulatory submissions for accuracy and completeness, ensuring timely submission to regulatory agencies and sponsors

Knowledge & ExperienceEducation:

• Bachelor's degree in life sciences, health-related field, or equivalent experience required

Experience:

• Minimum of 5 years of experience in regulatory affairs within the clinical research industry
• Past employment in a site network organization is preferred

Credentials:

• ACRP-CP certification, or commitment to obtain ACRP certification within the next 6 months

Knowledge and Skills:

• In-depth knowledge of regulatory guidelines (e.g., FDA, ICH-GCP) and protocol requirements related to regulatory affairs in clinical trials
• Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders
• Leadership experience, with the ability to mentor and supervise junior staff members
• Proficiency in regulatory submission software, document management systems, Google Suite, and Microsoft Office applications

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