Senior Digital Standards Policy and Implementation Manager (REMOTE)

USP • Rockville, MD

6d • Remote

About The Position

USP is seeking a Senior Digital Standards Policy and Implementation Manager to lead the development of internal and external policy frameworks that support the creation, governance, and regulatory adoption of Digital Standards. This role bridges regulatory policy, digital standardization, and practical implementation, ensuring that USP’s Digital Standards align with global regulatory expectations, structured data initiatives, and emerging digital quality workflows. The ideal candidate has expertise in regulatory science, data standards, and digital transformation, and is able to translate policy into actionable implementation guidance. This role is critical in shaping how regulators, industry, and technology partners understand and apply Digital Standards in analytical development, quality control, and regulatory submissions. As pharmaceutical development and manufacturing continues its digitalization journey, USP is seeking to take an active, collaborative role in helping advance digitalization of analytical development and quality control workflows through the delivery of chemical reference and analytical method standards directly into digital environments. You will help define how Digital Standards are governed, validated, implemented, and communicated across the pharmaceutical ecosystem This role is remote, with an expected travel commitment of up to 20% for policy workshops, conferences, and external engagement

Requirements

• Bachelor’s degree in regulatory affairs, pharmaceutical sciences, data science, public policy, or a related field.
• Minimum of 10 years of experience in regulatory policy, regulatory affairs, data standards, structured submissions, or digital quality/CMC transformation.
• Experience contributing to regulatory submissions (IND, NDA, BLA, variations) or structured CMC data submissions.
• Experience developing or influencing regulatory policy frameworks, standards governance models, or structured data models (e.g., PQ/CMC, eCTD, XML/JSON schemas).
• Familiarity with global regulatory environments, including FDA, EMA, ICH, and other international regulatory bodies.
• Ability to translate complex scientific, regulatory, or technical concepts into clear policy positions or implementation guidance.
• Experience with digital transformation in pharmaceutical development, including FAIR principles, structured data approaches, or digital quality systems.
• Strong analytical and writing skills for policy documents, regulatory engagement materials, and technical implementation guidance.
• Experience engaging with standards organizations, policy forums, or regulatory working groups.
• Experience in pharmaceutical, scientific, healthcare, nonprofit, or regulated industries.

Nice To Haves

• Master’s degree in life sciences (chemistry, biology, pharmaceutical science, engineering, etc.) or business.
• Experience drafting regulatory comments or participating in regulatory consultations.
• Hands‑on experience with structured data frameworks.
• Participation in formal standards‑setting groups.
• Entrepreneurial mindset prioritizing action and experimentation.
• Familiarity with existing digital ecosystems, including vendors, software packages, and emerging technologies and trends.
• Demonstrable commitment to public health/patient safety/consumer protection.
• Comfortability with ambiguity.

Responsibilities

• Develop internal policy frameworks for the creation, governance, structure, and lifecycle management of USP Digital Standards.
• Lead the development of USP’s external policy positions for FDA, EMA, ICH, WHO, and other regulatory bodies related to Digital Standards, structured data submissions, and digital quality expectations.
• Draft regulatory comment letters, issue briefs, white papers, and policy analyses that articulate USP’s perspectives on digital standardization, data governance, and digital regulatory pathways.
• Represent USP in external policy‑focused working groups, standards bodies, and technical committees (e.g., ICH, ISO, PQ/CMC, Pistoia Alliance).
• Translate policy decisions into actionable implementation guidance, schemas, metadata requirements, and integration specifications for use by industry, technology vendors, and internal product teams.
• Collaborate with USP scientific, digital, and standards‑setting teams to ensure Digital Standards are developed in alignment with regulatory expectations and structured data principles.
• Provide subject‑matter expertise during Digital Standards pilot efforts, ensuring that pilots validate USP’s policy frameworks and deliver value to stakeholders.
• Monitor global regulatory and policy trends and provide insights and recommendations to internal leadership.
• Develop internal guidance documents, governance models, SOPs, and best practices that ensure consistency and compliance in the creation of Digital Standards.
• Support the development of thought‑leadership content on Digital Standards and digital regulatory transformation.

Benefits

• USP provides the benefits to protect yourself and your family today and tomorrow.
• From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level