Director, Medical, Legal, & Regulatory (MLR) Operations (Pharma/Biotech)

Location: United States

Base compensation: $210,000–$225,000 per year

Company

hirify.global operates in the pharmaceutical and biotechnology sector.

What you will do

• Own the end-to-end MLR operating model, including intake, routing, review cycles, approvals, archiving, governance, SOPs, and best practices.
• Manage the MLR technology ecosystem, including Veeva Vault PromoMats, in partnership with IT and Compliance.
• Build enterprise review calendars, forecast submission volumes, plan reviewer capacity, and lead operational readiness for launches, new indications, and label changes.
• Coordinate Medical, Legal, Regulatory, Marketing, and Commercial leadership and facilitate governance meetings that drive timely decisions.
• Define performance metrics such as submission volume, cycle time, SLA adherence, review rounds, and aging, translating insights into process improvements and capacity plans.
• Maintain audit and inspection readiness, support training and onboarding, and escalate timeline or compliance risks with data-backed recommendations.

Requirements

• Bachelor’s degree required; an MBA, MPH, or related advanced degree is advantageous.
• At least 10 years of experience in pharmaceutical or biotechnology organizations, including significant promotional review, MLR/PRC operations, content operations, or closely related experience.
• Hands-on experience owning or significantly shaping an MLR review process and managing a platform such as Veeva Vault PromoMats.
• Strong working knowledge of FDA promotional regulations, OPDP guidance, and the PhRMA Code.
• Experience managing complex, multi-stakeholder processes under tight deadlines in a matrixed organization.
• Proven ability to influence and hold accountable senior leaders without formal authority.

Nice to have

• Experience in a global, matrixed pharmaceutical or biotechnology organization.
• Process improvement, project management, or change management experience.
• Experience partnering with Legal and Regulatory review leadership on governance or policy matters.
• Experience leading MLR platform implementations or major process redesigns.
• Experience helping a small, growing company scale its portfolio and operations.

Culture & Benefits

• Strategic role with direct influence on MLR governance, compliance, and operational performance.
• Cross-functional work across Medical, Legal, Regulatory, Compliance, Marketing, Commercial, and IT functions.
• Opportunity to design scalable processes and improve review speed, quality, and accountability.
• Compensation determined using relevant skills and experience, job location, and internal equity.