- The RIM Consultant is accountable for entering and managing regulatory information in the authoritative system for submissions, approvals and associated product data. This individual will create and monitor CMC Change Controls for commercial and investigational products and well as create CMC information with detailed metadata to capture new, submitted and approved records in the RIM tool.
- The RIM Consultant will function as a leader; providing guidance to colleagues, facilitating RIM sub-teams, planning work, and assessing resource load. The role will interact with global regulatory managers, country managers and other regulatory associates to ensure that data in the RIM tool is available in a complete, accurate, and timely manner.
- The RIM Consultant will create RIM reports/ metrics, analyze data trends and monitor data quality in the RIM system. They will focus primarily on CMC and function as a super-user across all system-supported processes and data requirements. Drive efficiency by advising functional area colleagues on their use of the system. Recommend process simplification understanding functional area perspective.
- Functions as a process expert for CMC change control in the RIM system. Utilize strong working knowledge of related processes such as labeling revisions and registrations updates.
- Executes operational aspects of assigned regulatory processes to ensure compliance.
- Contribute to implementation plans for a new CMC data quality program.
- Draft material to communicate the goals and changes to end users.
- Execute daily data stewardship activities and is able to identify CMC compliance issues. Inform end-users of defects and issues to be corrected.
- Prepare monthly metrics, assess trends and communicate issues that need escalation.
- At the request of management, prepare data in supports of governance meetings.
- Supports and participates in the development of process optimization.
- Manages daily workload in addition to work on process improvements and/or system enhancements.
- Plans and leads small projects including activity/ milestone creation and tracking to completion, communication of progress to key stakeholders and senior leadership, identification of risks and issues.
- Minimum of a BS/BA in a relevant scientific or technical field.
- Minimum of 3 years work in Regulatory Affairs or minimum of 5 years of pharmaceutical industry experience.
- Experience with CMC Change Control and labeling processes in a pharmaceutical environment.
- Demonstrates excellent critical thinking skills in daily work, in alignment with group/company objectives.
- Demonstrates an understanding of the procedures and decision-making process of relevant Health Authorities.
- Strong understanding and practical experience in regulatory operations.
- Regulatory Data Management experience and an understanding of electronic records management rules, including ALCOA+.
- Understanding of system validation / testing, and electronic records regulations.
- Project management experience managing people in a matrix and estimating resource needs.
- Microsoft office - advanced knowledge of Excel (templates, formulas and macros), PowerPoint and Word.
- SQL experience.
- Report and dashboard creation experience (Veeva Vault preferred).
Strong communication and change management skills.