Associate Director, Regulatory Operations Systems

The Opportunity:

The Associate Director, Regulatory Operations Systems role contributes to the development, implementation, and governance of regulatory operation systems. This role serves as the subject matter expert for RIM, regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. Core responsibilities include driving RIM and other RO systems projects across the business, guiding the team through challenges and aligning with the overall business strategy and business development.

• Support and lead activities related to regulatory operation infrastructure and system maintenance, guiding the team through challenges and aligning with the overall business strategy.

• Contributes to the development, implementation, and governance of RIM and publishing system.

• Provides independent leadership and direction on regulatory specifications for RIM systems, working closely with cross-functional teams to achieve shared goals.

• Promotes regulatory information quality, reporting, and development and monitoring of KPIs and metrics to ensure quality.

• Monitor regulatory metadata quality and consistency across the system; identify, investigate, and drive remediation of data quality issues.

• Manages and oversees vendor(s) in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships.

• Support inspection readiness activities by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable.

• Partner cross-functionally with Regulatory Affairs, Quality, IT, and other stakeholders to continuously improve regulatory archiving and information management processes.

• Contribute to the development and maintenance of SOPs, work instructions, and best practices related to regulatory operations and RIM.

Required Skills, Experience and Education:

• Bachelor’s degree required; advanced degree preferred.

• Minimum of 7–10 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or related functions within the pharmaceutical or biotechnology industry.

• Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management.

• Strong working knowledge of global regulatory submissions and health authority correspondence processes.

• Proven ability to apply metadata practices in a regulated environment.

• Experience supporting inspection readiness and responding to regulatory or business-critical document requests.

• Strong attention to detail, organizational skills, and ability to manage work independently in a fast-paced environment.

• Excellent written and verbal communication skills, including the ability to train and guide cross-functional stakeholders.

Preferred Skills:

• Prior experience with regulatory submission publishing processes; hands-on publishing experience a plus.

• Experience supporting regulatory due diligence activities for business development, licensing, or mergers and acquisitions.

• Extensive experience in global drug development regulations, regulatory submissions, lifecycle management, and information management processes.

• Experience working in emerging or mid-size biotechnology organizations.

• Experience contributing to process improvement initiatives related to regulatory systems or information management.

• Experience managing vendors and contracts, including overseeing project deliverables and ensuring compliance.

• Ability to work effectively in a matrix structure and complex environments, demonstrating leadership, problem-solving, and flexibility.

  #LI-Hybrid  #LI-SH1