Director, Digital Standards & Regulatory Science

US Pharmacopeia; Rockville (MD); On-site; USD 167,000 - 238,000; Full time

Job summary

The U.S. Pharmacopeial Convention (USP) seeks a scientific and regulatory leader for its Digital Standards Business Unit in Rockville, MD.

The role is accountable for defining the scientific framework for USP’s digital pharmacopeial standards and building a coalition of regulators, government stakeholders, and industry partners. Success includes establishing principles and workflows, securing internal alignment, and engaging regulators, standards bodies, and manufacturers to align the field

Qualifications

• 10+ years of progressive experience in pharmaceutical sciences, regulatory science, or closely related discipline.
• 7+ years of people management across advocacy, scientific, policy, and program functions.
• Proven ability to implement changes across a matrixed organization and shape governance, operating models, workflows, and policy frameworks.
• Demonstrated ability to convene regulators, government stakeholders, standards bodies, and manufacturers around a shared framework.
• Advanced degree or recognized leadership in scientific/regulatory working groups.

Responsibilities

• Define the scientific framework governing USP’s Digital Standards and translate it into enterprise strategy and operating model.
• Oversee lifecycle governance and ensure scientific rigor across product lines.
• Lead regulator, government, and industry engagement strategy to build alignment and champions.
• Represent USP in external scientific/regulatory forums and drive thought leadership.
• Develop and oversee policy frameworks, ensuring practical implementation assets for stakeholders.
• Oversee portfolio-level alignment, budgets, forecasts, and KPIs for Digital Standards.
• Lead multidisciplinary teams and establish scalable operating rhythms.

Skills

Pharmaceutical science

Regulatory science

Stakeholder engagement

People leadership

Strategic governance

Education

Advanced degree in scientific discipline (PhD/PharmD/MS)

Job description

The U.S. Pharmacopeial Convention (USP) seeks a scientific and regulatory leader for its Digital Standards Business Unit in Rockville, MD.

The role is accountable for defining the scientific framework for USP’s digital pharmacopeial standards and building a coalition of regulators, government stakeholders, and industry partners. Success includes establishing principles and workflows, securing internal alignment, and engaging regulators, standards bodies, and manufacturers to align the field