Spandana Mannepalli
Fort Worth
Summary
Dedicated Regulatory Affairs professional with 8 years of experience in pharmacovigilance and global regulatory affairs. Holds a Master's in Regulatory Affairs, complemented by a Master's in Pharmaceutics and a Bachelor's in Pharmacy. Expertise in global regulations and standards ensures compliance with domestic and international requirements. Strong analytical skills support effective problem-solving and decision-making.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Global Regulatory Affairs Specialist
CooperVision
Victor, NY
05.2022 - Current
- Reduced conventional submission times by 50% in timely medical device reporting to applicable regulatory authorities like US FDA, Canada's Health Canada, UK MHRA and EU countries etc.
- Supported regulatory teams in product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies, ensuring compliance and timely approvals.
- Optimized & developed regulatory strategy for submissions to FDA and other regulatory bodies globally.
- Analyzed adverse event severity, prioritized cases based on risk, and executed appropriate follow-up and escalation procedures.
- Facilitated the preparation and maintenance of technical documentation to support global and regional regulatory activities and submissions.
- Maintained global post market surveillance reports, meeting defined timelines to facilitate ongoing regulatory compliance and stakeholder communication.
- Developed and maintained robust monthly, quarterly, and annual adverse event reporting related reports to support regulatory and business stakeholders.
- Developed cross-functional partnerships with Medical Affairs, Clinical R&D, Quality Affairs, and Regulatory teams to enhance pharmacovigilance activities, safety reporting, and compliance throughout product lifecycle.
- Developed, reviewed, and maintained Standard Operating Procedures (SOPs) in alignment with the latest regulatory guidelines, ensuring compliance with industry standards and organizational policies.
Regulatory Affairs Specialist
Centre for Pharmaceutical Cleaning Innovation
Hillsborough Township, NJ
02.2022 - 04.2022
- Executed regulatory projects, including documentation of HBEL monographs, to ensure compliance with industry standards.
- Established SOPs to enhance operational efficiency.
- Reviewed and ensured compliance with applicable regulations and standards.
Regulatory & Quality Associate
Washington Homeopathic Products Inc.
Berkeley Springs, WV
06.2021 - 01.2022
- Conducted comprehensive regulatory reviews of Instructions for Use (IFUs), product labeling, batch records, specification sheets, and promotional materials to ensure compliance with FDA requirements and industry standards.
- Supported external regulatory audits (from FDA) by coordinating audit activities, preparing documentation and ensuring organizational processes complied with regulatory requirements.
- Improved quality by conducting internal audits to identify procedural gaps and recommend corrective and preventive actions.
- Coordinated with QC, Production, and Sales departments to align efforts toward achieving quality objectives.
- Executed thorough regulatory reviews of Instructions for Use (IFUs), product labeling, batch records, specification sheets, and promotional materials to ensure compliance with FDA regulations and industry standards.
- Collaborated with other departments like QC, Production and Sales to meet quality objectives.
Pharmacovigilance Analyst
Cognizant Technology Solutions
Hyderabad, India
04.2014 - 10.2016
- Maintained top 5% team ranking by delivering high-quality solutions consistently.
- Demonstrated proficiency in MedDRA for regulatory activities across projects.
- Contributed insights to periodic reports, including PSUR and DSUR.
- Identified and resolved backend database issues in Oracle and Argus application.
- Managed case processing for spontaneous and literature cases in the safety database.
Education
Masters - Regulatory Affairs and Quality Assurance
TEMPLE UNIVERSITY, School of Pharmacy
Philadelphia, PA05-2021
Masters - Pharmaceutics
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
Hyderabad, India12-2013
Bachelors of Education - Pharmacy
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
Hyderabad, India06-2011
Skills
- Regulatory Affairs: FDA Regulations, MDR Implementation, 21 CFR Parts 210, 211 & 820, ISO 13485, ICH Guidelines, CTD, Global Regulatory Intelligence
- Regulatory Submissions: 510(k), PMA, IND, NDA, Medical Device Post-Market Requirements, 510(k) Submission Strategy
- Quality Systems: QMS, cGMP, Biocompatibility (ISO 10993), Sterilization Validation (ISO 11135)
- Clinical Research: Good Clinical Practice (GCP)
- Pharmacovigilance: Good Pharmacovigilance Practices (GVP), Signal Management, Adverse Event Reporting
- Microsoft Office: Word, Excel, PowerPoint
Certification
- Drug Development Certificate (TEMPLE UNIVERSITY, School of Pharmacy) February 2020
- Writing in Sciences (Stanford University) August 2020
FIELDWORK EXPERIENCE
- Industrial training in R&D division of Dr. Reddy's Laboratories April 2013
- Industrial training at Espi Industries & Chemicals June 2010
Timeline
Global Regulatory Affairs Specialist
CooperVision
05.2022 - Current
Regulatory Affairs Specialist
Centre for Pharmaceutical Cleaning Innovation
02.2022 - 04.2022
Regulatory & Quality Associate
Washington Homeopathic Products Inc.
06.2021 - 01.2022
Pharmacovigilance Analyst
Cognizant Technology Solutions
04.2014 - 10.2016
Masters - Pharmaceutics
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
Bachelors of Education - Pharmacy
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
Masters - Regulatory Affairs and Quality Assurance
TEMPLE UNIVERSITY, School of Pharmacy