Associate Director, Regulatory Business Operations

• General Description:

• The Associate Director, Regulatory Business Operations will play a critical role in enabling our company's expanding external partnership model, including incubator collaborations, co-development arrangements, minority investments, and in-licensing/out-licensing opportunities.

Sitting within the Regulatory Affairs organization, this role serves as the operational hub connecting Business Development (BD), Regulatory functions, Finance, and Governance. This individual will act as an extension of the Chief of Staff, driving the operational processes that ensure Regulatory is positioned to support external opportunities with speed, precision, and discipline. The role combines intake and triage management, resource forecasting, governance coordination, reporting, and light project management into a single, high‑impact function. This is a unique opportunity for a highly organized, analytical, and collaborative professional to shape how Regulatory supports a rapidly evolving portfolio of internal and external collaborations.

• Essential Functions of the job:
• 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). + Work with Senior leadership to 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, in close collaboration and alignment with Regulatory Affairs teams and other R D and corporate functions. + 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 to ensure contractual terms reflect GRA's governance, operational, and oversight needs.
• 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. + Acting as project manger, ensure 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. + Coordinate timelines, deliverables, and cross‑functional alignment. + Lead or support 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.
• Required
• + Bachelor's degree with 8+ OR 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.