Associate Director, Regulatory Business Operations

About the role

The Associate Director, Regulatory Business Operations plays a critical role in enabling BeOne’s expanding external partnership model. This role sits within the Regulatory Affairs organization and serves as the operational hub connecting Business Development (BD), Regulatory functions, Finance, and Governance.

Responsibilities

• Intake & Triage Management
• Serve as the primary operational point of contact for BD-initiated opportunities.
• Manage the intake process, ensuring complete and consistent information capture.
• Collaborate with SMEs to conduct rapid opportunity characterization (scope, risks, timelines, Regulatory impact).
• Identify and assign the Regulatory Single Point of Contact for early-stage assessments.
• Develop, maintain and refine intake tools, templates, and workflows.
• Resource & Capacity Planning
• Lead the development of a validated, algorithm-based approach for estimating study-level Regulatory Affairs FTE needs.
• Track functional demand vs. capacity and identify gaps or constraints.
• Support forecast cycles and partner with Finance on budget implications.
• Contracting Support
• Coordinate GRA’s input into partnership contracts by gathering requirements, aligning stakeholders, and partnering with Legal and Procurement.
• Governance & Operating Rhythm
• Establish and coordinate governance forums related to external partnerships (e.g., BD–Regulatory syncs, LT updates).
• Prepare materials, decision summaries, and action logs.
• Act as project manager, ensuring timely follow-up and alignment across Regulatory functions.
• Maintain a consistent operating cadence that supports rapid decision-making.
• Tracking, Reporting & Insights
• Maintain the central tracker for all BD-related opportunities.
• Establish mechanisms for capturing actual resource utilization and cost, including timecard reporting in Workday or related systems.
• Develop dashboards and reports that provide visibility into pipeline, resource load, risks, and cycle times.
• Identify trends, bottlenecks, and opportunities for process improvement.
• Provide regular updates to Regulatory leadership and cross-functional partners.
• Project Management Support
• Provide PM support for high-priority or complex external engagements.
• Care for timelines, deliverables, and cross-functional alignment.
• Coordinate integration activities for in-license or acquisition scenarios.
• Ensure Regulatory deliverables are on track and risks are escalated appropriately.
• Strategic Partnership with GRA Chief of Staff
• Act as an operational extension of the Chief of Staff.
• Support strategic planning, prioritization, and escalation management.
• Contribute to the evolution of the operating model as the external partnership portfolio grows.

Requirements

• Bachelor's degree with 8+ years of experience in Regulatory Affairs, R&D Operations, Program/Portfolio Management, or a related function.
• Master's degree with 6+ years of experience in Regulatory Affairs, R&D Operations, Program/Portfolio Management, or a related function.
• Strong analytical and organizational skills with the ability to manage multiple complex workstreams.
• Demonstrated ability to work cross-functionally and influence without authority.
• Experience with resource planning, forecasting, or operational analytics.
• Excellent communication skills, including the ability to synthesize information for senior stakeholders.
• Comfort operating in ambiguity and building structure/processes where none exist.

Preferred Experience

• Supporting BD, external partnerships, or alliance management.
• Familiarity with Regulatory processes across clinical development, CMC, and submissions.
• Experience with dashboards, reporting tools, or operational systems.
• Background in consulting, PMO, or business operations.

Salary Range

$142,800.00 - $192,800.00 annually