Senior Regulatory Compliance Specialist

We are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team. This individual will play a critical role in ensuring that our laboratory operations are in compliance with relevant regulatory requirements.

Job Description:

• Work closely with cross-functional teams, including business stakeholders and IT personnel, to gather and document LIMS requirements.
• Assist in the analysis of 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 analyses 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.
• 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.

Required Skills and Qualifications:

• 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.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and dynamic work environment.

Others:

• Must have a B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries.
• Good interpersonal skills; Good written, oral and presentation skills.