Director, Digital Standards & Regulatory Strategy (Remote)

The U.S. Pharmacopeial Convention (USP); Rockville (MD); Remote; USD 167,000 - 238,000; Full time

Job summary

The U.S. Pharmacopeial Convention (USP) is seeking a scientific and regulatory leader for its Digital Standards Business Unit. You will define the scientific framework, build external partnerships, and ensure alignment across USP divisions to scale Digital Standards globally.

You will lead cross‑functional teams, engage regulators and industry bodies, and oversee the Digital Standards product portfolio. A senior, strategic thinker with robust scientific credentials is required, with a focus on

Qualifications

• 10+ years in pharmaceutical sciences, regulatory science, or related field.
• 7+ years of people management experience across multiple functions.
• Ability to influence senior stakeholders and shape governance.
• Experience aligning regulators, standards bodies and manufacturers.
• PhD/PharmD/MS or equivalent, or strong peer‑reviewed publications.

Responsibilities

• Define the scientific framework governing USP’s Digital Standards and translate it into the enterprise strategy.
• Oversee lifecycle governance and ensure scientific rigor across product lines.
• Govern Digital Standards integration with USP documentary standards and development processes.
• Build cross‑functional governance, metrics, and escalation for rapid yet compliant delivery.
• Lead external engagement with regulators, standards bodies, and industry partners.

Skills

Regulatory leadership

Stakeholder engagement

Strategic planning

Cross-functional leadership

Education

Advanced degree in scientific/pharmaceutical discipline

Job description

The U.S. Pharmacopeial Convention (USP) is seeking a scientific and regulatory leader for its Digital Standards Business Unit. You will define the scientific framework, build external partnerships, and ensure alignment across USP divisions to scale Digital Standards globally.

You will lead cross‑functional teams, engage regulators and industry bodies, and oversee the Digital Standards product portfolio. A senior, strategic thinker with robust scientific credentials is required, with a focus on