Veeva RIM Specialist
HybridHyderabad, Telangana, India
Job Summary
Administer and optimize global submission platforms including Veeva RIM, eCTD Manager, and Health Authority portals to enable smooth, compliant submission lifecycles. Compile, format, publish, validate, and archive electronic dossiers while troubleshooting metadata and gateway transmission errors. Coordinate routine maintenance, configuration updates, and release testing to keep systems aligned with regulatory standards. Partner with cross-functional global teams to align processes, resolve system issues, and provide technical guidance to superusers. Develop SOPs, work instructions, and templates to drive continuous improvement and ensure audit readiness. This role supports life-saving therapies worldwide within an inclusive, agile culture at Lonza.
Required Qualifications
- Minimum 5 years of experience in biotech, pharma, or life sciences, specifically within Regulatory Operations, Dossier Publishing, CMC, or Regulatory Systems Support
- Proven hands-on experience with Veeva RIM, eCTD Manager, publishing software, electronic document management systems, and Health Authority gateways
- In-depth understanding of regulatory publishing, eCTD validation, dossier lifecycle management, and metadata troubleshooting
- Bachelor's degree in Chemistry, Biology, Biotechnology, Pharmaceutical Sciences, Regulatory Affairs, Information Technology, or relevant practical/industry experience
- Fluent in written and spoken English, with a strong ability to translate technical concepts for cross-functional global teams
- Proactive, solution-oriented mindset with high attention to detail, accountability, and strong organizational skills
- Must be able to work primarily in the office with flexibility to work remotely for 20% of your time (three days per week in office)
- Relocation assistance is available for eligible candidates and their families, if needed
Desired Qualifications
- Preferred Veeva RIM certification, eCTD publishing training, or equivalent regulatory systems background
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