Regulatory Affairs Specialist jobs in Gilbert, AZ

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

Responsible for understanding, interpreting, and implementing Good Clinical Practice (GCP) drug development guidance and regulations, as well as TD2’s internal controlled documents for clinical research trials conducted at TD2. Applies regulatory knowledge and drives change to ensure operational compliance.

Essential Functions:

• Support trial operational teams with regulatory compliance by providing expertise in GCP regulations surrounding clinical conduct of domestic and international oncology research trials.
• Understand industry best practice for conducting clinical research trials as related to GCP regulatory guidelines.
• Assist in writing, refinement, and consistency of controlled documents (Standard Operating Procedures [SOPs], Clinical Working Guidelines [CWGs], training instructions, and technical processes to support regulatory guidelines and industry best practices.
• In collaboration with Clinical management, lead efforts to ensure overall quality and compliance of clinical trials conducted at TD2.
• Provide training and guidance on GCP compliance during clinical project team meetings.
• Establish and implement a framework for monitoring the quality and compliance of trials conducted at TD2 in collaboration with the Quality Assurance and Regulatory departments.
  • Assist with required periodic regulatory submissions (e.g., IND Annual Report).
  • Support the deviation system for investigation of unexpected incidents and non-conformances relating to GCP clinical activities, ensuring that deviations are appropriately documented.
  • Ensure corrective and preventive actions are identified, implemented, and ongoing compliance is monitored.
  • Oversee site level essential document collection and submission to the Trial Master File (TMF) for ongoing clinical trials.
  • Interact with vendor activities on clinical trials as needed.
• Prepare and deliver department GCP compliance trainings, ensuring accurate record keeping within the Quality Management System (QMS).
• Prepare department for and participate in Sponsor audits and regulatory agency inspections, including resolution of applicable audit findings.
• Keep abreast of industry trends with respect to regulatory policies and procedures within the United States (US), Europe (EU), and rest of world (ROW).
• Provide guidance to clinical operations teams on outlining and managing trial risks.
• Perform other related duties as assigned.

Job Requirements:

• Bachelor degree in a scientific discipline (e.g., biology, chemistry, biochemistry, immunology, pharmacy), with advanced degree desirable.
• Minimum of three (3) years of significant relevant GCP experience in clinical research drug development within the pharmaceutical/biotechnology or contract research organization (CRO) industry.
• Experience auditing and/or monitoring clinical trials.
• Preferred exposure to Regulatory Affairs department.
• Comprehensive knowledge and experience interpreting and applying drug development guidelines and regulations, including but not limited to:
  • Good Clinical Practice (GCP)
  • Food & Drug Administration (FDA) Guidance
    • Center for Drug Evaluation and Research (CDER)
    • Center for Biologics Evaluation and Research (CBER)
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) General Considerations for Clinical Studies
  • European Clinical Trial Regulation (EU-CTR)

Required Specialized/Technical Skills:

• Must possess knowledge of domestic (FDA), European (EU) and Rest of World (ROW) regulatory requirements for conduct of oncology clinical research trials.
• Demonstrated advanced skills with Microsoft Office products is required (e.g., Outlook, Word, Excel, PowerPoint, SharePoint, OneNote).
• Excellent written and verbal communication skills.
• Strong interpersonal skills with ability to work effectively in a matrix organizational structure.
• Strong organizational skills and attention to detail.
• Self-directed with ability to meet deadlines, prioritize work, take initiative for follow-up of outstanding issues, complete assigned tasks, handle multiple tasks simultaneously, and work both with a team and independently.

Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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