Pharmaceuticals; Biotechnology; Research

Director, Medical, Legal, & Regulatory (MLR) Operations

United StatesOnsiteFull TimeDirector$210,000–$225,000 /yrPosted 1 month agoVisa sponsorship available

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Required skills

promotional materials
medical materials
training materials
regulated materials
compliance
FDA
OPDP
PhRMA Code
Veeva Vault PromoMats
process automation

Nice to have

global
matrixed organization
process redesign
governance
policy matters
platform implementations

Role summary

The Director, MLR Operations is responsible for the strategy, governance, and execution of the Medical, Legal, and Regulatory (MLR) review process for promotional, medical, training, and other regulated materials. This role involves designing scalable workflows, setting governance standards, and advising senior leadership. Success requires influencing stakeholders, balancing business needs with compliance, and driving process improvements. The Director will manage operational readiness for launches, facilitate cross-functional coordination, and define a performance framework to ensure process effectiveness, integrity, and continuous improvement while staying current on regulatory expectations.

Reports To: Sr. Director, Sales Training & Commercial Effectiveness

About This Role:

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.

What You'll Do:

Strategic Process Ownership

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

Planning, Prioritization & Delivery

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.

Cross-Functional Leadership & Influence

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.

Reporting, Compliance & Continuous Improvement

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

Who You Are:

You are a strategic and highly organized MLR operations leader who thrives at the intersection of compliance, process excellence, and business execution. You bring deep experience managing complex promotional review environments and have a proven ability to design scalable processes that balance speed, quality, and regulatory rigor. Known for your executive presence and professional assertiveness, you are comfortable influencing senior stakeholders, driving accountability, and navigating competing priorities in a matrixed organization. You pair strong analytical and problem-solving skills with sound judgment, using data and insights to identify risks, remove bottlenecks, and continuously improve performance. A trusted cross-functional partner, you communicate with clarity and credibility across Medical, Legal, Regulatory, Compliance, and Commercial teams. Most importantly, you are a detail-oriented leader who can connect day-to-day operational decisions to broader business objectives while ensuring the integrity and effectiveness of the MLR process.

Required Skills:

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

Preferred Skills:

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

Additional Information:

The base compensation range for this role is: $210,000 - $225,000. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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