Senior Associate, Regulatory Information Management
Pennsylvania - United States
Seeking an experienced and highly eager Regulatory Information Management professional for a Global Regulatory Affairs group. Looking for a strong candidate to provide global regulatory support for company's RIMS system and work cross-functionally with R&D, Regulatory Affairs as well as IT to support all documentation maintenance of the RIM system. If you have at least two years of RA experience in a pharmaceutical industry and have an interest in IT, then this role is for you.
- Assist in the writing development of SOPs, Training Materials and Manuals for Veeva Vault RIM; will work collaboratively with Regulatory Affairs and QA teams.
- Work closely with IT and global regulatory functions to support Veeva Vault RIM configuration requests and any system updates and releases
- Support all migrations requests and database entry from across R&D, Global Regulatory Affairs and IT, to ensure all information management needs are met and requests are handled timely and efficiently
- Support RIM users by leveraging top support and value from the Veeva Vault RIM suite of product systems
- Manage all user accounts in the RIMS system regarding all user permissions and restrictions and security profiles
- Interfaces with system and users to detect necessary ad hoc regulatory and compliance-related system updates; resolve any relevant request
- Bachelor's degree or equivalent experience is required with at least 2 years of Regulatory Affairs experience required within a pharmaceutical/biotech setting.
- Veeva Vault Regulatory Information Management software or equivalent preferred
- Direct experience and working knowledge of regulatory submissions requirements within pharmaceutical/biotech, per global health authorities and ICH guidelines.
- RIMS software proficiency is highly preferred
- Regulatory Operations experience is highly preferred
If you'd like to be considered for this position or interested in learning more, please contact Bria Gaber directly at firstname.lastname@example.org & (646) 430-1191.