Operations and Support Associate - Regulatory

Overview

The Operations and Support Associate- Regulatory supports Regulatory Affairs teams with operational use of regulatory systems. The role provides business user and Tech partner support, including issue resolution, system enhancements, training, communications, testing, and regulatory system administration.

What you'll do

• Provide input and support on business queries regarding regulatory and related systems functionality.
• Gather user requirements and identify impacts on other components of the system environment.
• Collaborate with Operations and Support colleagues on the impact of enhancements and change requests across systems.
• Resolve and escalate applicable incidents and act on user requests with Tech colleagues as necessary.
• Discuss business requirements, enhancements, and product roadmaps with business stakeholders.
• Support documentation of internal processes, user requirements, written standards, communications, and training content.
• Participate in informal testing and formal user acceptance testing for releases and changes.
• Support internal and external audits and Health Authority and License Partner inspection requests.
• Provide user guidance and support, including access and incident management tasks.
• Manage organization, personnel, and product profiles.
• Configure pharmacovigilance reporting rules for Health Authorities and License Partners.
• Provide consultation and troubleshooting support for user issues, document management, system management, and other problems.

What you'll need

• Bachelor’s degree in life sciences, information technology, or another related area.
• 8-10 minimum years of 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 principles as applied to configuration changes in a regulated environment.
• Strong troubleshooting and root-cause analysis skills, with the ability to manage and support tickets.
• Knowledge of regulatory requirements and submissions across EU, US, and global markets.
• Knowledge of JIRA backlog and requirement management.
• Ability to 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 communication skills, with a proven ability to interact well with all levels.
• Customer service orientation and ability to communicate professionally with diverse cross-functional non-technical and technical audiences.
• Experience in work requiring attention to detail and excellent follow-up.
• Ability to work independently, resolve issues with cross-functional teams, and operate with minimal supervision.

Nice to have

• Experience working within Agile delivery methodology with an understanding of the system development life cycle.

Details

• Location: Hyderabad, Andhra Pradesh, India.
• The company states that it has an agile working culture and encourages candidates to explore flexibility opportunities with the hiring team.