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Senior Scientific Affairs Manager
US PharmacopeiaSenior Scientific Affairs Manager contributing to USP's mission of public health through scientific engagement and standards. Driving strategies for high-quality medicines across the region with key stakeholders.
About the role
Key responsibilities & impact- Provide scientific guidance on USP–NF monographs, general chapters, analytical methods, validation approaches, and lifecycle management of USP Reference Standards
- Analyze regional scientific and regulatory trends to proactively shape regional scientific engagement strategies
- Strengthening USP’s influence within the regional scientific community by collaborating with science and if necessary, co-authoring technical white papers and peer-reviewed publications, and supporting the formation and operation of scientific advisory boards
- Integrate scientific insights into broader regional account strategies to drive long-term partnerships and impact
- Represent USP in high-level scientific, regulatory, and policy forums
- Able to identify and independently drive strategic scientific engagement projects with key stakeholders (both internal and external) with clear deliverables, timelines, and measurable impact
- Lead cross-functional initiatives requiring alignment across marketing, regulatory, sales, and global scientific teams
- Systematically capture and analyze regional scientific and regulatory trends in the region
- Translate insights into actionable recommendations that influence regional planning and global priorities
Requirements
What you’ll need- Master’s degree with 12-15 years or Ph.D. with 8–10 years of experience in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Chemistry, Biotechnology, or a related discipline
- Minimum of 5 years of experience working in pharmaceutical or biopharmaceutical development, quality, regulatory science, or analytical sciences
- Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products
- Demonstrated expertise in pharmaceutical analytical sciences, with strong working knowledge of USP–NF compendial standards, analytical methods, and reference standards
- Strong understanding of impurity control strategies, including organic, inorganic, elemental impurities, residual solvents, extractables and leachable
- Proficiency in English is required
- French language knowledge is additional and preferred.
Benefits
Comp & perks- Health insurance
- Retirement savings
- Paid time off
- Professional development opportunities
ATS Keywords
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Hard Skills & Tools
analytical methodsvalidation approachesUSP Reference Standardsanalytical testing procedurespharmaceutical analytical sciencesimpurity control strategiesbio-pharmaceutical developmentregulatory sciencequality assurancebiotechnology
Soft Skills
scientific guidancestrategic engagementcollaborationleadershipcommunicationproject managementanalytical thinkinginfluencerelationship buildingproblem solving
Certifications
Master’s degreePh.D.