Associate Director Regulatory Operations

Kaye/Bassman International; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

Kaye/Bassman International is seeking an Associate Director, Regulatory Operations for a commercial-stage biopharmaceutical client in New Jersey. The role drives global regulatory strategy through submission planning, cross-functional coordination, and hands-on ownership of the Veeva RIM environment.

You will lead submission planning across the portfolio, translate strategy into actionable plans, monitor KPIs, and partner with regulatory leads to ensure timely milestones.

Qualifications

• Bachelor's degree in life sciences or related field.
• 8+ years in Regulatory Operations within pharma/biotech.
• Deep hands-on expertise with Veeva RIM functionality and workflows.
• Global regulatory submission planning, tracking, and lifecycle management experience.

Responsibilities

• Develop and maintain integrated regulatory plans aligned with global development strategies; deliver portfolio-level reporting to leadership on submission progress and risks.
• Serve as SME for Veeva RIM across modules including Registrations, Submissions, Submission Content Planning, and Regulatory Objectives and Commitment Tracking
• Oversee end-to-end submission planning and tracking within Veeva RIM, including timelines, milestones, and health indicators
• Partner with Regulatory Affairs leads to translate regulatory strategy into actionable operational plans; support Health Authority interaction and commitment tracking
• Establish data standards, naming conventions, and controlled vocabularies; lead workflow optimization, lifecycle management, and continuous improvement initiatives
• Design and maintain SOPs and work instructions; lead process harmonization across programs and regions
• Develop and deliver training to drive adoption and consistent use of RIM processes
• Monitor KPIs on submission performance, cycle times, and system utilization; support system upgrades, validation, and issue resolution

Skills

Veeva RIM expertise

Regulatory submissions

Cross-functional leadership

Project management

Analytics & data governance

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Project

Smartsheet

Job description

My client, a commercial-stage biopharmaceutical company, has engaged us to identify an Associate Director, Regulatory Operations. This is a high-visibility role driving execution of global regulatory strategy through submission planning, cross-functional coordination, and deep ownership of the company's Veeva RIM environment.

The Opportunity: You will lead submission planning and tracking across the portfolio, ensuring timely delivery of regulatory milestones and providing leadership with clear visibility into progress and risk. As the subject matter expert for Veeva RIM, you will optimize regulatory processes, strengthen data governance, and enhance system effectiveness across the organization. Success in this role requires both strategic regulatory perspective and hands-on operational execution.

What You'll Do

• Develop and maintain integrated regulatory plans aligned with global development strategies; deliver portfolio-level reporting to leadership on submission progress and risks
• Serve as SME for Veeva RIM across modules including Registrations, Submissions, Submission Content Planning, and Regulatory Objectives and Commitment Tracking
• Oversee end-to-end submission planning and tracking within Veeva RIM, including timelines, milestones, and health indicators
• Partner with Regulatory Affairs leads to translate regulatory strategy into actionable operational plans; support Health Authority interaction and commitment tracking
• Establish data standards, naming conventions, and controlled vocabularies; lead workflow optimization, lifecycle management, and continuous improvement initiatives
• Design and maintain SOPs and work instructions; lead process harmonization across programs and regions
• Develop and deliver training to drive adoption and consistent use of RIM processes
• Monitor KPIs on submission performance, cycle times, and system utilization; support system upgrades, validation, and issue resolution

What You Bring

• Bachelor's degree in life sciences or related field
• 8+ years in Regulatory Operations within pharma/biotech
• Deep hands-on expertise with Veeva RIM functionality and workflows
• Demonstrated experience with global regulatory submission planning, tracking, and lifecycle management, including multi-region submissions
• Solid understanding of the clinical development process and regulatory submission pathways (IND, NDA, BLA, MAA)
• Experience managing cross-functional projects; familiarity with project management tools (Microsoft Project, Smartsheet)
• Ability to develop and deliver training that drives system and process adoption
• Exposure to process improvement methodologies (Lean, Six Sigma) is a plus
• Analytical mindset with the ability to turn RIM data into insights for decision-making