Regulatory Compliance Professional

Job Summary:

We are seeking a highly skilled Regulatory Compliance Senior to join our team. In this role, you will be responsible for ensuring compliance with industry regulations and standards.

The Regulatory Compliance Senior will work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. They will analyze business requirements related to LIMS functionality and enhancements, as well as laboratory workflows and processes to recommend and implement LIMS solutions.

• Gather and analyze business requirements related to LIMS functionality and enhancements.
• Analyze laboratory workflows and processes to recommend and implement LIMS solutions.
• Translate business needs into functional specifications and system configurations.
• Configure, test, and validate LIMS functionalities to meet business needs.
• Conduct impact analysis and risk assessments for LIMS changes and enhancements.
• Serve as a liaison between business users and technical teams to ensure effective communication and system alignment.
• Participate in business process mapping and workflow optimization to enhance LIMS utilization.
• Provide input on LIMS enhancements and new feature development to improve system performance.
• Assist in troubleshooting, identifying, and resolving LIMS-related issues.
• Conduct user training sessions and provide end-user support.
• Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively.
• Identify opportunities for automation and process improvement within laboratory operations using LIMS.
• Master Data Design Configuration
• Analyze the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets.
• Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS.
• Maintain data integrity, consistency, and version control across the system.
• Implement changes and updates to LIMS master data in alignment with business and regulatory needs.
• Collaborate with cross-functional teams to ensure accurate data migration and system integration.
• Troubleshoot and resolve issues related to master data configuration and system functionality.
• Work on optimizing data structures and database management within LIMS.

To qualify for this role, you must have:

• A strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles.
• Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards.
• Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance.
• Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations.
• Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories.
• Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms).
• Knowledge of system integration with ERP, MES, or other enterprise applications.
• Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS.
• Hands-on experience in master data configuration within LIMS platforms.
• Experience in system validation, testing, and documentation.
• Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization.
• Understanding of relational databases and SQL queries.
• Experience with scripting or automation tools for LIMS is a plus.
• Understanding of API integrations, web services, and middleware solutions for LIMS.
• Ability to troubleshoot system and data issues efficiently.
• Strong problem-solving and analytical skills.
• Excellent communication and stakeholder management abilities.
• Ability to work independently and as part of a cross-functional team.
• Strong attention to detail and commitment to data integrity.
• Adaptability to dynamic business and regulatory environments.
• Demonstrated track record in project management, governance, and reporting
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management.
• Prior experience of supporting Audits / Inspections

As a Regulatory Compliance Senior, you will enjoy a competitive salary and benefits package, including:

• A comprehensive health insurance plan.
• A retirement savings plan.
• A generous paid time off policy.
• Access to ongoing training and professional development opportunities.
• A collaborative and supportive work environment.

This is an exciting opportunity to join a dynamic team and contribute to the success of our organization. If you are a motivated and experienced Regulatory Compliance professional, please submit your application today