Lakshmi S Bommareddy
Summary
Proficient in current APAC regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Experienced administrative professional knowledgeable about registrations, audits, inspections and other industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Specialist III
Cepheid
07.2023 - Current
- Serves as RA lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments, or software, in global regions outside US and EU to ensure OTD (on time delivery) product launches
- Prepares the regulatory strategy and submissions and interacts cross-functionally to ensure OTD product registrations
- Interacts with regulatory agencies/health authorities to resolve queries and to obtain and maintain product approvals globally
- Serves as in-country representative to gather and interpret new and changed regulations and guidelines
- Implements continuous improvements and efficiencies using DBS (Danaher business system) tools
- Reviews and interprets regulatory intelligence information
- Shares RI with RA and other cross functional teams and provides training to other associates as needed.
- Performed and documented quality control checks to maintain compliance with company initiatives.
Regulatory Affairs Specialist II
Cepheid
11.2021 - 06.2023
- Demonstrated in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
- Identify relevant guidance documents, international standards, regulations and provide interpretive assistance to cross functional team members (R & D, Sales, Marketing, QMS) for product development
- Worked on preparing and submission of regulatory dossier to APAC international registrations, change notifications, new product registrations, renewals for new product developments activities and product maintenance for existing approved products
- Worked on Canadian License (including Special Access program; SAP and Investigational Testing authorization; ITA) Knowledge in preparing and submission of 510(k) pre-market notification and approvals, IVDD to IVDR cut-over
- Review product promotional materials, labeling, Instruction for Use supporting pre-approval and post marketing requirements
- Regulatory review and approval of design, manufacturing, labeling, packaging-related changes in compliance with applicable regulations and providing Regulatory Change Assessments through RCA
- Communicates with in-country Regulatory Affairs personnel to facilitate global clearances/approvals
- Organizes and maintains files such as Certificates from Notified Bodies CFS and CFG and other RA related material
- Provided regulatory feedback through weekly meetings with the RA Leads and constant communications with Cepheid’s cross-functional teams (Global RA, R&D, Medical Affairs, Clinical, Marketing, Quality, etc.) Prepare formal written reports, PowerPoint presentations, and documents for distribution within work units and regions
- Knowledge on different databases like Trackwise, Agile documentation system
Drug Safety Specialist
IQVIA
04.2021 - 11.2021
- Receive, triage, review, and process data from various sources on time, while meeting quality standards
- Perform data entry for tracking and safety database, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations, and ensuring reports are sent to the customer within assigned deadlines
- Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement
- Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
- Liaise with different functional team members, e.g., project management, clinical, data management; health care professionals e.g., investigators, medical monitors, site coordinators and designees to address project related issues.
Drug Safety specialist
United BioSource Corporation
07.2016 - 11.2020
- Responsible for review of SUSAR and FDA final rule cases to ensure that reporting criteria is met and maintenance of reporting rules within the client safety database
- Responsible in reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates, and other destinations
- Complete all on-time submissions to all applicable reporting destinations
- Generate, review, and transmit to all schedule reports to Global Health Authorities including but not limited to FDA, European Agencies, Health Canada etc
- Generate CIOMS I form, 3500 FDA MedWatch Form or similar to global partners based on defined timelines
- Supported the collection, review and dissemination of regulatory intelligence impacting pharmacovigilance operational activities.
Quality Control Analyst
InvaGen Pharmaceuticals Inc.
10.2014 - 03.2016
- Sampling and testing of raw materials, intermediates and finished products using Standard operating procedures associated ‘wet’ chemistry and instrumental techniques (HPLC, IR, UV)
- Preparing quality control reports, including analytical reports for raw materials and finished products, Certificates of Analysis (CoA) and stability reports
- Creating and executing method development and method validation test protocols for finished products and generating the analytical methods
- Stability testing of products for new formulations using physical (pH, viscosity) and instrumental (HPLC, UV) techniques
- Writing analytical specifications using current pharmacopeias and reviewing existing analytical specifications
- Writing/reviewing Standard Operating Procedures (SOPs)
- Calibrating analytical equipment
- Supporting all QC activities by complying with Good Manufacturing Practice (GMP), company Health and Safety Policies.
Hub Labeling Manager
Pfizer
08.2012 - 09.2014
- Areas of expertise include regulatory labeling of generics, package component labeling, eCTD labeling submissions and proofreading
- To prepare, review the local labels with respect to core data sheet for EU, US, Asian regions and prepare the dossier for submission to HA
- To prepare, review the patient information leaflets (PIL’s)
- Repeat labeling process - To prepare the labels for various formulations based on the primary label content
- To write and review the module 2.5 Clinical Overview for the labeling changes (SmPC, USPI and CCDS) for submission to the Health Authorities
- Compare and review the deviations among the core data sheet and the local label and identify the safety impact of the deviation and suggesting the gap mitigation plan
- Proofread and QC (Data and style consistency check) of the draft updated CCDS, CO and LPD.
Education
PharmD (Doctor of Pharmacy) -
Manipal University
01.2012
MBA (HCS) -
Manipal University
01.2012
Bachelor of Pharmacy -
Osmania University
01.2009
Skills
- Regulatory Affairs
- Medical devices and Drugs
- Technical Documentation
- International Regulations
- Regulatory Agency Applications
- Audits
- Drug Labeling and artwork services
- Patient information leaflets
- Drug Safety and Pharmacovigilance
- ARGUS Safety, MedDRA, WHODD
- Safety Report Writing
- Pharmaceutical Quality Control
- Agile
- Trackwise
- Power BI
- Microsoft word
- Excel
- Powerpoint presentations
Timeline
Regulatory Affairs Specialist III
Cepheid
07.2023 - Current
Regulatory Affairs Specialist II
Cepheid
11.2021 - 06.2023
Drug Safety Specialist
IQVIA
04.2021 - 11.2021
Drug Safety specialist
United BioSource Corporation
07.2016 - 11.2020
Quality Control Analyst
InvaGen Pharmaceuticals Inc.
10.2014 - 03.2016
Hub Labeling Manager
Pfizer
08.2012 - 09.2014
PharmD (Doctor of Pharmacy) -
Manipal University
MBA (HCS) -
Manipal University
Bachelor of Pharmacy -
Osmania University
Similar Profiles
Monithai ThyMonithai Thy
Manufacturing Associate at CepheidManufacturing Associate at Cepheid
Paloma GardnerPaloma Gardner
Senior Production Trainer at CepheidSenior Production Trainer at Cepheid
Ronald RodriguezRonald Rodriguez
Material Handler 3 at CepheidMaterial Handler 3 at Cepheid
REYNALDO JR YRREVERREREYNALDO JR YRREVERRE
Manufacturing Associate III at CepheidManufacturing Associate III at Cepheid
Deepthi GovapudiDeepthi Govapudi
Pharma Regulatory Affairs Research Associate - III at Aurobindo PharmaPharma Regulatory Affairs Research Associate - III at Aurobindo Pharma