Darryl Clarke

About Darryl Clarke

Accomplished global regulatory operations leader with experience in overseeing and managing regulatory and compliance functions and initiatives of a pharmaceutical organization. Background in managing Regulatory Operation and Pharmaceutical Project Management to support new drug registrations and application maintenance. Thorough understanding of cross-functional operational aspects of dossier planning, preparation, and management. In-depth hands-on experience in the planning, creating, and submission of regulatory dossiers in the US and outside the US.Experienced in creating, documenting, and training regulatory processes that underpin drug development, such as US FDA IND maintenance activities, safety data processing, regulatory submission management, medical writing, and regulatory document publishing. Core Competencies include:Global Regulatory Guidelines, Regulations & Best Practices | Regulatory Operations Management | Computer System Validation Team Leadership | Electronic Publishing Systems (eCTD Xpress/ISI Publisher/DocuBridge) & Document Management System (Documentum, SharePoint, Veeva) Installation, Validation & Training | Thought Leadership

Experience

1. Senior Director, Global Head of Regulatory Operations

   Structure Therapeutics

   May 2024 — Present · South San Francisco, CA, US

   I am responsible for carrying out the planning, scheduling, and coordination of submission obligations, in collaboration with Regulatory colleagues, those from other functional areas, and outside vendors. Additionally, I own the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management.Essential Duties and responsibilities• Manage assigned projects and closely collaborate with personnel from the Regulatory and other departments (as with vendors), to coordinate and implement high quality submission output. Be accountable for the management of submission projects, including the preplanning, tracking, assembly, submission, and archiving of regulatory documents.• I use project management and planning tools as required, work to ensure assembly of all submissions are planned, coordinated, and delivered on time, and adhere to company and agency standards.• Identify appropriate resources/business strategies needed to support submission publishing activities.• Collaborate as a member of project teams, meeting regularly to identify and resolve open issues and to assess quality, delivery, and effectiveness, while developing opportunities for regulatory submission process improvement.• Maintain the submission-tracking process in support of short and long-term submission and resource planning.• Maintain the company’s Regulatory Archive up-to-date and Diligence ready.• Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function; ensure that Company’s practices are in conformance with the latest health authority and industry submission standards• Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents to ensure that said documents meet requirements as \'Approved for Submission

Education

• DeVry University

  Bachelor, Computer Information Systems

  1995 — 1999

Skills

• Pharmaceutical Industry
• Fda
• Life Sciences
• U.s. Food and Drug Administration (Fda)
• Regulations
• Medical Devices
• Ich-Gcp
• Document Management
• Drug Development
• Gxp
• Good Clinical Practice (Gcp)
• Software Documentation
• Edc
• Ctms
• Glp
• Data Management
• Regulatory Operations
• Validation
• Oncology
• Sharepoint
• CRO
• Regulatory Affairs
• Lifesciences
• Computer System Validation
• Documentum
• Good Laboratory Practice (Glp)
• Quality Assurance
• Regulatory Submissions
• Regulatory Requirements
• Ectd