Director, Medical, Legal, & Regulatory (MLR) Operations
About The Position
The Director, MLR Operations owns the strategy, governance, and end-to-end operation of the Medical, Legal, Regulatory review process for the organization. This role ensures all promotional, medical, training, and other regulated materials move through review and approval accurately, compliantly, and on time. Beyond process execution, this person is the strategic owner of the MLR operating model — designing scalable workflows, setting governance standards, and serving as a trusted advisor to senior Medical, Legal, Regulatory, and Commercial leadership. Success requires professional assertiveness to hold senior stakeholders accountable, sound judgment to balance speed to balance business urgency, review capacity, and process requirements while ensuring compliance risks are surfaced to appropriate functional decision makers. The Director is accountable for the effectiveness, integrity and operational performance of the MLR process, while Medical, Legal, Regulatory and Compliance functions retain accountability for their respective substantive review decisions.
Requirements
- Bachelor's degree required; advanced degree (MBA, MPH, or related) a plus
- 10 years of experience in pharmaceutical/biotech with significant experience in promotional review, MLR/PRC operations, content operations, or a closely related function.
- Additional experience in medical affairs, regulatory, legal review, or compliance operations, including experience operating at a strategic or leadership level is a plus.
- Direct, hands-on experience owning or significantly shaping an MLR review process, including platform ownership (e.g., Veeva Vault PromoMats)
- Strong working knowledge of FDA promotional regulations, OPDP guidance, and the PhRMA Code
- Demonstrated success managing complex, multi-stakeholder processes under tight deadlines in a matrixed organization
- Track record of influencing and holding accountable senior leaders (Director level and above) without formal authority
Nice To Haves
- Experience in a global, matrixed pharma/biotech organization
- Demonstrated process-improvement, project management, or change management capability.
- Prior direct experience partnering with Legal and Regulatory review leadership on governance or policy matters
- Experience leading or contributing to MLR platform implementations or major process redesigns
- Demonstrated experience working with small growing companies as they expand their portfolio and scale their business
Responsibilities
- Own the MLR operating model end-to-end — intake, routing, review cycles, approvals, and archiving — and continuously evolve it as volume, therapeutic areas, and regulatory expectations change
- Set governance standards, SOPs, and best practices for the review process, and ensure consistent adoption across Medical, Legal, Regulatory, and Marketing
- Serve as business owner for the technology ecosystem (e.g., Veeva Vault PromoMats), partnering with IT/Compliance on configuration, upgrades, and process automation opportunities
- Identify systemic bottlenecks and lead cross-functional process improvement initiatives, using data to justify changes to senior stakeholders
- Build and maintain enterprise-wide review calendars across teams, launches, and material types (promotional, training, medical, and other)
- Lead MLR operational readiness for new product launches, indications, label changes, and other high-volume business events, including submission volume forecasting, reviewer capacity planning, critical path calendars and escalation protocols.
- Serve as the primary strategic point of coordination between Medical, Legal, Regulatory, Marketing, and Commercial leadership on all review matters
- Facilitate and, where needed, redesign MLR review governance meetings to drive efficient, decisive outcomes among senior reviewers
- Establish and reinforce clear roles, service-level expectations, timelines, and escalation protocols across reviewer functions and organizational levels; constructively address deviations that put quality, compliance, or business timelines at risk.
- Build credibility and trusted-advisor relationships across the matrix; influence decisions and behavior change without direct authority
- Proactively escalate risks to timelines or compliance with clear, data-backed rationale and recommended solutions, not just flagged problems
- Role-based training and onboarding for material owners, reviewers, agencies and other stakeholders.
- Establish company requirements for submissions and approvals for external agencies and partners to adhere to.
- Define and maintain a MLR performance framework including submission volume, cycle time, SLA adherence, review rounds, aging, etc. Translate insights into capacity plans, process improvements and leadership recommendations.
- Ensure audit- and inspection readiness through accurate, well-governed review documentation and records retention
- Stay current on evolving FDA, OPDP, and PhRMA Code expectations and partner with regulatory, legal, and compliance to translate evolving regulatory requirements, guidance, internal policies and enforcement trends into MLR process
- May mentor or oversee junior process coordinators supporting the MLR function
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What This Job Offers
Job Type
Full-time
Career Level
Director
