Associate Director, Regulatory Business Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main operational point of contact for opportunities initiated by Business Development (BD).

• Oversee the intake process, ensuring that information is captured completely and consistently.

• Collaborate with Subject Matter Experts (SMEs) to perform rapid opportunity characterization, including scope, risks, timelines, and Regulatory impact.

• Work alongside Senior leadership to identify and designate the Regulatory Single Point of Contact for preliminary assessments.

• Create, maintain, and enhance intake tools, templates, and workflows.

• Lead the creation of a validated, algorithm-driven method for estimating study-level Regulatory Affairs Full-Time Equivalent (FTE) needs, in close cooperation with Regulatory Affairs teams and other R&D and corporate functions.

• Monitor functional demand against capacity and identify any gaps or constraints.

• Assist with forecast cycles and collaborate with Finance on budget-related implications.

• Coordinate the Global Regulatory Affairs (GRA) input into partnership contracts by gathering requirements, aligning stakeholders, and collaborating with Legal and Procurement to ensure that contractual terms meet GRA’s governance, operational, and oversight needs.

• Establish and facilitate governance forums related to external partnerships, such as BD–Regulatory syncs and leadership team updates.

• Prepare materials, decision summaries, and action logs. In the role of project manager, ensure timely follow-up and alignment across Regulatory functions.

• Maintain a consistent operating rhythm that supports swift decision-making.

• Keep the central tracker updated for all BD-related opportunities.

⛳️ Requirements

• Bachelor's degree with 8+ years OR a master's degree with 6+ years of experience in Regulatory Affairs, R&D Operations, Program/Portfolio Management, or a related field.

• Strong analytical and organizational abilities with a knack for managing multiple complex workstreams.

• Proven capability to work cross-functionally and influence without direct authority.

• Experience in resource planning, forecasting, or operational analytics.

• Exceptional communication skills, including the ability to synthesize information for senior stakeholders.

• Ability to operate comfortably in ambiguous situations and establish structure or processes where none currently exist.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness