Lokesh Marimuthu
Dublin,Ireland
Summary
Regulatory Affairs Specialist with 3+ years of hands-on experience supporting global regulatory submissions (EU, US, APAC) and life-cycle management across human and veterinary product portfolios. Proven expertise in eCTD publishing, dossier compilation, licence maintenance, regulatory intelligence, and cross-functional coordination. Strong working knowledge of FDA, EMA, ICH, GCP guidelines and regulatory systems including PharmaReady, Veeva Vault, Lorenz Validator, and Adobe Acrobat (ISI Toolbox). Adept at supporting product registrations, variations, renewals, and regulatory compliance activities to ensure timely approvals and high-quality submissions.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
Work history
Junior Regulatory Associate
Navitas Life Sciences Inc
Chennai, India
08.2022 - 07.2023
- Assisted in formatting, validating and publishing regulatory documents in eCTD format under supervision.
- Supported coordination of cross-functional documentation and data collection for regulatory submissions.
- Performed quality control checks on documents using PharmaReady Veeva Vault and Lorenz Validator.
- Resolved basic publishing issues and maintained organisation of regulatory submission files.
- Supported responses to health authority questions by preparing validated and structured documents.
- Learned evolving international regulatory guidelines gaining understanding in dossier assembly and eCTD structure.
- Presented findings at company meetings ensuring everyone was kept informed about departmental updates.
Regulatory Associate
Navitas Life Sciences Inc
Chennai, India
07.2023 - 01.2025
- Ensured compliance with global regulatory requirements by maintaining up-to-date knowledge of regional guidelines and integrating them into submission processes and documentation practices.
- Coordinated cross-functional document collection, review cycles, and approval workflows to meet strict submission timelines and regulatory deadlines.
- Maintained and organized regulatory documentation repositories, ensuring version control, document integrity, and easy retrieval for audits and inspections.
- Assisted in the preparation and submission of responses to Health Authority questions, deficiency letters, and information requests within defined timelines.
- Supported lifecycle management activities by tracking submission statuses, commitments, and regulatory milestones across multiple products and markets.
- Collaborated with publishing and IT teams to troubleshoot system-related issues in eCTD tools, ensuring uninterrupted submission workflows.
- Performed gap analysis of submission documents to identify missing or inconsistent information and ensured completeness prior to submission.
- Contributed to continuous improvement initiatives by identifying process inefficiencies and recommending solutions to enhance regulatory operations.
- Supported audit and inspection readiness activities by preparing documentation and ensuring compliance with internal and external quality standards.
- Maintained accurate regulatory databases and trackers to monitor submission progress, approvals, and ongoing commitments.
- Assisted in training new team members on regulatory processes, tools, and submission standards to ensure consistency and efficiency.
Food service supervisor
Applegreen
Saggart, Dublin, Ireland
02.2025 - Current
- Supervised overall cleanliness and hygiene standards across service and kitchen areas, ensuring strict adherence to SOPs and practices aligned with GMP principles for contamination control and workplace safety.
- Monitored and enforced cleaning schedules, sanitation procedures, and waste management processes to maintain a controlled and compliant environment.
- Ensured proper handling, storage, and segregation of materials, supporting product integrity and minimizing risks of cross-contamination.
- Maintained accurate records of cleaning activities, service logs, and daily checklists, demonstrating strong adherence to Good Documentation Practices (GDP) and traceability requirements.
- Trained and guided staff on hygiene standards, SOP compliance, and best practices, ensuring consistency and continuous improvement in operational quality.
- Conducted routine inspections and identified deviations from established procedures, implementing corrective actions to maintain compliance and audit readiness.
- Collaborated with cross-functional teams including kitchen and service staff to ensure smooth operations while maintaining high-quality and safety standards.
- Ensured compliance with food safety regulations and internal policies, reflecting strong awareness of regulated working environments similar to pharmaceutical quality systems.
- Handled customer queries and escalations professionally, maintaining service quality while ensuring adherence to operational and safety standards.
Education
Master of Science - Pharmaceutical Business & Technology
Griffith College
Dublin 02.2025 - 06.2026
Bachelor of Science - Pharmacy
The Tamil Nadu Dr. M.G.R. Medical University
Chennai, India 08.2017 - 05.2022
Skills
- Global Regulatory Submissions (EU, US, Asia-Pacific)
- eCTD Publishing & Dossier Authoring
- Variations, Renewals, Supplements & MA Lifecycle
- CTD Module Preparation (Modules 1–5)
- Regulatory Compliance & Licence Maintenance
- IMP/Clinical Submissions Support
- Regulatory Intelligence & Risk Assessment
- Cross-functional Project Coordination
- Adobe Acrobat (ISI Toolbox) & Advanced Formatting
- eSubmission Gateways (US-FDA ESG, EU Systems)
- Document Validation (Lorenz Validator)
- Quality & Audit Readiness
Accomplishments
- Delivered 60+ regulatory submissions with 100% compliance and zero major deficiencies.
- Reduced submission errors by 30% through enhanced validation and quality checks.
- Improved documentation efficiency by 25% by streamlining processes and standardising workflows.
- Achieved 95% on-time submission rate across multiple global markets (EU, US, APAC).
- Supported faster regulatory approvals by minimising agency queries and rework cycles.
- Handled 10+ concurrent submissions, consistently meeting tight deadlines without quality compromise.
- Increased team productivity by 20% through knowledge sharing and process improvements.
Awards
- Recognized for contribution to initial NDA submission to the US FDA and awarded Best Performer – SMB Team for outstanding accuracy and delivery.
- Received multiple client appreciations from Cipla and Pfizer for high-quality regulatory submissions and consistent performance excellence.
- Commended for maintaining zero-error submissions and demonstrating exceptional attention to detail in global regulatory projects.
Timeline
Food service supervisor
Applegreen
02.2025 - Current
Master of Science - Pharmaceutical Business & Technology
Griffith College
02.2025 - 06.2026
Regulatory Associate
Navitas Life Sciences Inc
07.2023 - 01.2025
Junior Regulatory Associate
Navitas Life Sciences Inc
08.2022 - 07.2023
Bachelor of Science - Pharmacy
The Tamil Nadu Dr. M.G.R. Medical University
08.2017 - 05.2022