Operations and Support Associate - Regulatory

gsknch; Andhra Pradesh; On-site; INR 2,000,000 - 3,200,000; Full time

Job summary

Haleon is seeking an Operations and Support Associate - Regulatory to back the regulatory affairs teams. You will support regulatory systems, gather requirements, run testing, and assist with audits and inspections.

The role involves collaborating with IT and business users to enable compliant, efficient regulatory processes. The ideal candidate has 8–10 years in pharma or consumer goods, with experience in regulatory operations, CSV principles, and familiarity with Veeva Vault RIMS and JIRA.

Qualifications

• Bachelor's degree in life sciences, IT or related field.
• 8–10 years in pharma or consumer goods with regulatory ops experience.
• Experience with Veeva Vault RIMS or equivalent RIM systems.
• Knowledge of regulatory data management and lifecycle processes.
• Understanding of CSV in regulated environments.

Responsibilities

• Provide input and support on queries regarding regulatory systems.
• Gather user requirements and assess impacts on system environment.
• Collaborate with Operations to implement changes and enhancements.
• Resolve incidents and manage user requests with Tech teams.
• Contribute to testing, UAT, and release readiness.
• Support audits and inspection requests related to regulatory systems.
• Configuration of PV reporting rules for Health Authorities and License Partners.
• Provide consultation and troubleshooting for user issues and document management.

Skills

Regulatory operations

GxP validation

Troubleshooting

Root-cause analysis

Communication skills

Agile delivery

Education

Bachelor's degree in life sciences or IT

Tools

Veeva Vault RIMS

JIRA

Job description

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture. Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

About the role

The Operations and Support Associate- Regulatory, supports the Regulatory Affairs teams with operational use of Haleon's regulatory systems to carry out the business functions of regulatory affairs associated capabilities. The role will involve interaction with business users and Tech partners as a primary support role, including business user support, system enhancements, training, communications, and testing. User support includes request and issue resolution and general user assistance.

Role Responsibilities

• Provides input and support on queries from business regarding regulatory and related systems functionality as assigned.
• Gather user requirements and identify impacts on other components of the system environment.
• Work in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems.
• Accountable for resolving and escalating applicable incidents, act upon user requests in collaboration with Tech colleagues as necessary.
• Contribute to discussions with business stakeholders to understand business requirements, enhancements, and product roadmap, support the documentation of internal processes, user requirements, written standards, communications and training development and content.
• Participate in all aspects of informal testing and formal user acceptance testing for releases and changes.
• Support internal and external audits and HA and LP inspection requests as needed. Provide user guidance and support including access and incident management tasks.
• Responsible for management of organization, personnel and product profiles.
• Responsible for configuration of PV reporting rules for Health Authorities and License Partners.
• Provide consultation and troubleshooting support for user issues, document management, system management and other problems.

Basic Qualifications:

• Bachelor's degree in life sciences or information technology or other related area.
• 8-10 minimum years pharmaceutical industry and/or consumer goods industry knowledge and experience.
• Experience with Veeva Vault RIMS configuration or equivalent RIM systems.
• Experience in regulatory operations, submissions or publishing systems.
• Experience in regulatory data management and lifecycle processes.
• Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment.
• Strong troubleshooting and root-cause analysis skills, with the ability to manage & support tickets.
• Knowledge in Regulatory requirements and submissions across EU, US and Global markets.
• Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus.
• Knowledge of JIRA backlog and requirement management
• Support User testing and execution oversight.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Customer service orientation and ability to communicate professionall