About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job W2 Only, not open for C2C We are seeking a highly motivated and detail-oriented Business Analyst (BA) with expertise in Regulatory Information Management (RIM) systems, particularly Veeva RIM, to support our evolving regulatory landscape. This role will focus on CMC regulatory processes, eCTD 4.0 readiness, and system optimization to align with regulatory changes and operational best practices. The ideal candidate will bring experience in process analysis, data mapping, and requirements gathering, and have a working knowledge of Veeva Vault and related systems in a regulatory context. Primary Responsibilities • Act as the liaison between Regulatory Affairs, CMC, and IT teams to assess current regulatory systems and define future-state processes. • Lead or contribute to initiatives supporting eCTD 4.0 implementation, with a focus on CMC data requirements and document lifecycle management. • Analyze and map current regulatory data and workflows, identifying gaps and areas for improvement in system functionality and process alignment. • Support change management and system enhancement initiatives in Veeva Vault RIM related to new regulatory requirements (e.g., IDMP, eCTD 4.0). • Facilitate stakeholder workshops and interviews to gather and document business needs, functional requirements, and pain points. • Develop and maintain process documentation, user stories, SOPs, and configuration documentation related to RIM system usage. • Provide subject matter expertise on CMC regulatory data and its use in electronic submissions and content planning. • Assist in system testing (UAT), configuration review, and go-live support for system updates or new features. Additional Responsibilities • Performs other related duties and assignments as required Qualifications • 4+ years of experience as a Business Analyst or similar role in the biopharma regulatory domain. • Hands-on experience with Veeva Vault RIM (or similar regulatory platforms). • Strong understanding of CMC regulatory processes and data requirements. • Familiarity with eCTD format and upcoming eCTD 4.0 changes. • Proven experience in process analysis, data mapping, and documentation creation. • Excellent interpersonal, communication, and stakeholder engagement skills. • Experience working in clinical-stage or commercial biopharma companies. • Understanding of structured data initiatives like IDMP or SPOR. • Exposure to regulatory submission management tools and frameworks. • Knowledge of industry best practices for Regulatory Affairs and GxP systems. Education & Certifications • Bachelor’s degree in Life Sciences, Information Systems, or related field. Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: • Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. • Operate other office productivity machinery, such as a calculator, scanner, or printer. • Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Compensation Salary/Hourly Rate Range (W2): USD 75.00 - 85.00 The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here: https://usdm.com/careers