Requirements
- Bachelor's degree in a life sciences discipline or comparable field; advanced education preferred.
- Minimum of eight years of experience in Regulatory Operations, with progressive leadership roles and compliance duties within regulatory affairs or other GxP-related areas.
- Track record of managing global regulatory submission teams and overseeing major electronic submissions, including INDs, CTAs, NDAs, and MAAs in eCTD format.
- Hands-on experience in deploying or managing a Regulatory Information Management (RIM) system, including workflow configuration, data governance, role-based access controls, and integration with publishing platforms.
- Proven ability to lead compliance initiatives such as SOP development and oversight, participation in audits and inspections, and maintaining data integrity programs in line with 21 CFR Part 9 and EU Annex 11 for electronic records and computerized systems.
Work Arrangement
Remote (Worldwide)
Work Arrangement
Remote (Worldwide)
Other
This role may require up to 15% travel beyond the local region, including overnight stays.
