Lakshmi Kadiyala
Sligo
Summary
Regulatory Affairs Specialist & PMP® Certified Project Manager skilled in managing technical documentation for CE marking and ensuring compliance with EU MDR 2017/745. Expertise in managing Notified Body submissions, executing process improvement methodologies, supporting regulatory strategies, and conducting compliance analysis. Proficient in labelling compliance, post-market surveillance, and change management within the medical device sector. Previous roles include Project Manager and Manager of eTMF Implementation, highlighting a strong foundation in cross-functional leadership and operational efficiency.
Overview
2
2
Certificate
12
12
years of professional experience
Work History
Regulatory Affairs Specialist
Abbott Ireland
Sligo
11.2021 - Current
- MDR Technical Documentation: Manage the creation and maintenance of Technical Documentation for CE marking (Life Cycle Management) to ensure full compliance with MDR 2017/745.
- Notified Body Liaison: Support submissions to Notified Bodies and Competent Authorities for initial applications, scope extensions, and significant change notifications.
- Regulatory Strategy: Support the creation and implementation of regulatory strategies by collaborating with Business Unit Regulatory Affairs, R&D, and Quality teams.
- Compliance Analysis: Conduct detailed reviews of General Safety and Performance Requirements (GSPR) and State of the Art (SoA) assessments, ensuring all technical and clinical evidence meets current regulatory standards.
- Labelling Compliance: Perform detailed regulatory review of product labelling, Instructions for Use (IFU), and packaging artwork to ensure alignment with MDR/IVDR requirements.
- Post-Market Surveillance (PMS): Lead the regulatory review of PMS reports (including PSUR and PMPF Plan & Reports), ensuring real-world data is accurately reflected in Technical Files and Risk Management updates.
- Change Management: Process regulatory impact assessments for Site Design Plan changes and manufacturing process updates, ensuring all modifications align with global filings and Change Control procedures.
- Audit Participation: Key participant in all internal and external company audits (including Notified Body and Regulatory Agency inspections), ensuring full compliance with ISO 13485 and MDSAP requirements.
- Global Compliance: Monitor upcoming global key market regulations and support impact assessments to help the Business Unit prepare for compliance changes.
- Diagnostics
- Managed the preparation and submission of regulatory reports and documents within stipulated deadlines.
Project Manager
TransPerfect
Carlow
10.2020 - 10.2021
- Assign and oversee all the internal collaborative team as points of contact for all new and existing clients.
- Respond to internal requests for new project initiatives; collaborate with various members of the Production and Sales teams to assess the scope of work and produce cost estimates.
- Be an expert in Trial Interactive features and functionality.
- Work with the Professional Services and Development teams to recommend new features and functionality to improve the product and reduce manual activities.
Manager eTMF Implementation
TransPerfect
Pune
04.2019 - 08.2020
- Drive successful programs and processes to optimize customer satisfaction and retention, pricing management, technical assistance, and sales to new customers through internal operations.
- Continuous refinement of delivery processes, addressing tactical customer and internal needs while focusing on the long-term strategic role of delivery of the team.
- Track room build projects' progress.
- Serve as an internal and external management escalation point related to configuration team.
- Participate in the TI Steering Committee, required for company-wide initiatives to drive success, innovation, and improvements.
- Build and strengthen a close working relationship with Support Services and Technical Services to ensure cooperation and efficiency for every project.
- Accountable for time management and reporting of his/her projects and assigned groups and/or service areas – i.e., utilisation metrics, project/program metrics.
- Contribute to the creation of new platform features and enhancements with global development team.
- Lead and manage daily configuration team operations for assigned accounts and/or regions.
- Resource Management and Capacity Planning with leadership team.
- Oversee the execution of User Acceptance Testing for release and client-specific projects.
- Ensure reporting line's compliance to regulations and standards.
Clinical Document Lead
TransPerfect
Pune
04.2017 - 03.2019
- Process and evaluate Adverse Events / SAEs/ Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
- Assess adverse event reports for seriousness, causality, and expectedness as per applicable labeling, consulting the Medical Safety Expert whenever needed.
- Ensure accurate and consistent coding of medical history, drugs, and adverse event terms as per medical dictionaries like MedDRA.
- Generated Annual Safety Updates, Periodic Safety Reports, and cumulative safety reports, ensuring thorough data retrieval, analysis, and quality control.
- Generate concise, accurate and well-written case narratives.
- Reconcile SAEs in accordance with project specific guidelines.
- Conduct and analyse, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries.
- Lead preparation of standard operating procedures, process related documents and product guidance documents.
- Mentor and train new hires or other associates.
- Participate in audits or inspections.
- Attend various meetings; contribute to the presentation of safety process at various meetings.
- Suggested process improvements that enhanced team collaboration and overall performance.
- Provided ongoing feedback to Development Team on necessary features and enhancements based on user needs.
- Respond to client requests for new project initiatives; collaborate with various members of the Production and Sales teams to assess the scope of work and produce cost estimates.
- Take a proactive role in learning about clients' industry, business needs and company culture, educating the Project Team, identifying new business opportunities, and providing a high level of service.
- Managed individual employees and groups to ensure effective team performance.
- Set and fulfill client expectations.
- Executed special projects and duties as assigned.
Drug Safety Associate
Jazz Pharmaceuticals
Oxford
02.2016 - 03.2017
- Processes adverse event information received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports.
- Receive and book-in adverse events in the drug safety database, including sending acknowledgements to partners, performing duplicate searches and data entry of adverse events information.
- Triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Drug Safety and Pharmacovigilance department management.
- Reviews case information for appropriate distribution to internal and external business partners.
- Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities and business partners.
- Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes.
- Adheres to company templates and guidelines for documentation and communications.
- Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database.
- Follows company processes and guidelines for case management and closure activities.
- Participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures.
- Assist in coordinating the department's workflow.
- Distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines; distribute reports via EVWeb, E2B and/or e-mail.
- Ensure compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents.
- Performs other activities as directed by Drug Safety and Pharmacovigilance management.
- Assists with special projects or performs other activities under the direction of the Drug Safety and Pharmacovigilance department management.
Drug Safety Associate
Covance
Maidenhead
11.2014 - 06.2015
- Expedited reporting of cases to worldwide regulatory agencies, ensuring compliance with required timelines.
- Evaluates adverse event reports, assesses regulatory status which is seriousness and expectedness/relatedness to prioritise workload.
- Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
- Coded adverse events using MedDRA to ensure precision and regulatory compliance.
- Determines expectedness/limitedness against appropriate label.
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
- Entry of safety data onto adverse event database(s) and tracking systems.
- Identifies clinically significant information missing from initial reports and ensures its collection.
- Ensures case receives appropriate medical review.
- Prepares follow-up correspondence consulting the medical staff accordingly.
- Reported endpoints to clients, regulatory authorities, ethics committees, investigators, and Covance project personnel, ensuring adherence to study timelines.
- Conducted independent QC of AE reports, enhancing accuracy and reliability for team members.
- Performed Quality checks and tracked the SAE files for auditing submissions.
- Participated in query reconciliation tasks.
- Handled additional queries from clients and entered data into the database, followed up on SAEs, and prioritised according to client requirements.
Education
Master of Science - Pharmaceutical Regulatory Affairs
Institute of Technology
Carlow, Ireland09-2021
Master of Research - Biotechnology
University of Northumbria
Newcastle, UK09-2011
Master of Science - Biochemistry
Andhra University
Kakinada, India09-2009
Bachelor of Science - Biotechnology
Andhra University
Kakinada, India08-2007
Skills
- CE Marking and ISO 13485 Compliance
- Regulatory Compliance
- EU MDR 2017/745
- Technical Documentation
- Strategic Regulatory Affairs
- Notified Body Relations
- Global Strategy
- Project Management
- Audit participation
- Change management
- Documentation management
- Process Improvement
- Team collaboration
- Communication excellence
- Time efficiency
Languages
English
Proficient
C2
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Certification
- Project Management Professional (PMP®) – Project Management Institute (PMI) | Certified May 2026
- Lean Six Sigma Green Belt (ICGB) – IASSC / PeopleCert | Certified June 2026
Timeline
Regulatory Affairs Specialist
Abbott Ireland
11.2021 - Current
Project Manager
TransPerfect
10.2020 - 10.2021
Manager eTMF Implementation
TransPerfect
04.2019 - 08.2020
Clinical Document Lead
TransPerfect
04.2017 - 03.2019
Drug Safety Associate
Jazz Pharmaceuticals
02.2016 - 03.2017
Drug Safety Associate
Covance
11.2014 - 06.2015
Master of Science - Pharmaceutical Regulatory Affairs
Institute of Technology
Master of Research - Biotechnology
University of Northumbria
Master of Science - Biochemistry
Andhra University
Bachelor of Science - Biotechnology
Andhra University