Job Title: Regulatory Submission Systems Specialist (Veeva RIM)

Location: The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed.

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).

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• A variety of benefits dependent on role and location.

• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

• 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.

What we are looking for:

• 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.

About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.