Associate Director Regulatory Affairs (Operations)

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The Associate Director, Regulatory Affairs Operations leads the end-to-end execution of regulatory operational activities, ensuring the efficient, compliant, and timely delivery of global regulatory submissions. This role provides hands-on leadership and oversight of day-to-day operations across submissions, publishing, regulatory systems, SOPs, and vendor management, serving as a key partner to Regulatory Affairs and cross-functional stakeholders.

This position is critical to strengthening operational control, reducing risk, and alleviating execution bottlenecks by driving accountability for operational excellence. Through effective management of regulatory systems (e.g., Veeva, DocuBridge), publishing processes, and vendor performance, the Associate Director enables proactive issue resolution, early risk identification, and continuous process improvement.

Working in close partnership with the Senior Director of Regulatory Operations, this role allows for a clear separation of execution and strategy. The Associate Director ensures consistent, high-quality operational delivery, enabling the Senior Director to focus on enterprise strategy, capacity planning, and inspection readiness.

This is a hands-on leadership role requiring strong organizational capability, attention to detail, and the ability to manage complex regulatory deliverables in a fast-paced, evolving biotech environment.

Key Accountabilities

• Regulatory Operations Leadership
  • Lead the planning, coordination, and execution of global regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring compliance with global regulatory requirements and timelines.
  • Provide operational oversight of eCTD submission activities, partnering with external publishing vendors and internal stakeholders to ensure high-quality, timely deliverables.
  • In partnership with the Senior Director of Regulatory Operations, play a key role in establishing internal publishing capabilities, including being a partner in defining and leading implementation of publishing capability strategy.
  • Ensure accurate maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems.
• Process & System Management
  • Oversee regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and inspection readiness.
  • Serve as system administrator for regulatory systems (e.g., Veeva RIM) and act as the internal subject matter expert (SME), driving training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap.
  • Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements.
  • Drive the development and continuous improvement of regulatory operations processes, tools, and best practices to enhance efficiency, quality, and consistency.
• Team Leadership
  • Lead, mentor, and develop a small team of regulatory operations staff, fostering a high-performing and collaborative team.