Veeva RIM Specialist
Lonza · Hyderabad · onsite · Posted 28d ago
Undisclosed5–10 yrsfulltimeSourced from
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About this role
Job Summary
Responsibilities
Requirements
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Job Title: Regulatory Submission Systems Specialist (Veeva RIM)
Location: Hyderabad, India.
Step into a vital role in Hyderabad, India, where you will maintain and optimize the global regulatory systems that accelerate life-saving therapies to patients worldwide. In this position, you will collaborate with cross-functional global teams to drive submission excellence and ensure seamless, compliant regulatory operations.
This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (three days per week in office).
Responsibilities
- Drive Global Impact: Administer and optimize global submission platforms (Veeva RIM, eCTD Manager, Health Authority portals) to enable smooth, compliant submission lifecycles.
- Stakeholder Collaboration: Partner directly with the Head of Global Submission Support, IT, system vendors, and regional regulatory teams to align processes and resolve system issues.
- Core Publishing Operations: Compile, format, publish, validate, and archive electronic dossiers while troubleshooting metadata, publishing, and submission gateway transmission errors.
- System Upgrades Lifecycle Management: Coordinate routine maintenance, configuration updates, release testing, and change control activities to keep platforms aligned with regulatory standards.
- Mentorship Empowerment: Provide technical guidance, training, and operational support to Veeva RIM superusers and global regulatory stakeholders to elevate team capabilities.
- Process Enhancement: Develop and maintain SOPs, work instructions, templates, and user guides to drive continuous improvement and standard ways of working.
- Compliance Quality Assurance: Ensure data integrity, maintain system records, and support continuous audit readiness across all submission system activities.
Requirements
- Industry Experience: Minimum 5 years of experience in biotech, pharma, or life sciences, specifically within Regulatory Operations, Dossier Publishing, CMC, or Regulatory Systems Support.
- Technical Proficiency: Proven hands-on experience with Veeva RIM, eCTD Manager, publishing software, electronic document management systems, and Health Authority gateways.
- Domain Skills: In-depth understanding of regulatory publishing, eCTD validation, dossier lifecycle management, and metadata troubleshooting.
- Education Transferable Knowledge: Bachelor's degree in Chemistry, Biology, Biotechnology, Pharmaceutical Sciences, Regulatory Affairs, Information Technology, or relevant practical/industry experience.
- Certifications: Preferred Veeva RIM certification, eCTD publishing training, or equivalent regulatory systems background.
- Communication Collaboration: Fluent in written and spoken English, with a strong ability to translate technical concepts for cross-functional global teams.
- Attributes: Proactive, solution-oriented mindset with high attention to detail, accountability, and strong organizational skills.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
AgileDocument ManagementDossierBIOTECHoperational supportEctdbiologyChemistryChange ControlmetadataBiotechnologyoperationsmaintenanceInformation TechnologycompliancePharmaPharmaceuticalLife Sciences
About Lonza
Lonza
Pharma
174
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129 years old
Basel
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A prominent provider of healthcare solutions, focusing on innovative therapies for disease prevention and specialized ingredients for various industries.
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