Senior Digital Standards Policy and Implementation Manager
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Job Description
Senior Manager responsible for policy frameworks supporting Digital Standards at USP. Leading regulatory engagement and collaboration in the pharmaceutical ecosystem.
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.
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.
Benefits:
- company-paid time off
- comprehensive healthcare options
- retirement savings
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