ANIL KUMAR MALLEKEDI
Plymouth,MN
Summary
Regulatory Affairs professional with advanced expertise in post-market surveillance, regulatory submissions (510(k), PMA, NDA, IND), and QMS implementation. Demonstrated success in managing risks, ensuring FDA/EMA compliance, and fostering cross-functional collaboration. Proficient in regulatory documentation, product lifecycle management, and process optimization. Strong communicator and leader with a keen focus on developing global regulatory strategies.
Overview
3
3
years of professional experience
Work History
Post Market Surveillance & Regulatory Specialist
Thermofisher Scientific
12.2021 - 12.2022
- Led post-market surveillance efforts, analyzing safety data to identify potential safety signals in regulatory affairs
- Developed risk management strategies within regulatory affairs to maintain product benefit-risk profiles
- Authored regulatory affairs submissions, including PSURs, PASS, and RMPs, in compliance with global regulations
- Managed timely reporting of individual case safety reports (ICSRs) to health authorities in regulatory affairs
- Coordinated cross-functional teams to integrate regulatory affairs insights into labeling and marketing strategies
- Developed comprehensive documentation for regulatory submissions, resulting in expedited approvals.
- Strengthened relationships with regulatory authorities through transparent communication and proactive engagement.
Associate Post Market Surveillance & Regulatory Specialist
PPD
11.2019 - 12.2021
- Supported post-market surveillance, collecting and analyzing safety data for regulatory submissions
- Assisted in preparing safety reports, risk management plans, and regulatory documentation
- Developed and maintained SOPs to ensure compliance with global safety reporting requirements
- Reviewed adverse event reports and coordinated responses to health authorities
- Monitored global regulatory changes and updated internal processes accordingly
- Coordinated responses to inquiries from regulators, demonstrating commitment to transparency and cooperation.
- Improved product labeling accuracy by conducting thorough reviews and implementing corrective actions where needed.
Education
Master of Science - Regulatory Affairs & Services
St Cloud State University
Plymouth, MN04.2025
Doctor Of Pharmacy -
Palamuru University
Mahabubnagar, India09.2020
Skills
- Post-Market Surveillance (PMS)
- Regulatory Submissions (510(k), PMA, NDA, ANDA, IND, CE Mark)
- Risk Management
- MDD
- MDSAP
- Compliance Management
- FDA
- EMA
- ISO 13485
- ICH Guidelines
- Product Recall Management
- Regulatory Strategy
- Lifecycle Management
- Clinical Trial Applications and Management (IND, BLA, IDE, CTD)
- Standard Operating Procedures (SOPs)
- Regulatory Documentation Review (IND, BLA, Clinical Trial Submissions, Annual Reports)
- Labeling Compliance
- Global Regulatory Monitoring and Compliance
- Cross-Functional Collaboration with R&D, Quality, and Marketing Teams
- International Submissions (Health Canada, PMDA, TGA)
- Regulatory Affairs Writing
- ECTD Submissions
- Quality Management Systems (QMS) Implementation
- CAPA (Corrective and Preventive Actions)
- Internal and External Audit Management
- Supplier Quality Management and Audits
- Supplier Qualification and Risk Management
- Process Validation and Design Validation
- Design Control and Risk Management
- Non-Conformance Management and Resolution
- Root Cause Analysis and Problem Solving
- Risk-Based Quality Assessments and Risk Management
- Continuous Improvement (Six Sigma, Lean, Kaizen)
- Compliance with ISO 13485
- ISO 9001
- Quality Assurance in Manufacturing and Product Lifecycle
- Regulatory and Quality Documentation Management
- Inspection Readiness and Regulatory Audit Preparation
- Training and Development on Quality Standards
- Quality Metrics and Key Performance Indicators (KPIs) Tracking
- Process Improvement and Optimization
- Post-Market Surveillance Integration in QMS
- Process Risk Management
- Supplier Audits
- Supplier Qualification
- Clarity
- Active Listening
- Adaptability
- Presentation Skills
- Written Communication
- Regulatory Writing
- Stakeholder Engagement
- Negotiation Skills
- Prioritization
- Organization
- Goal Setting
- Delegation
- Flexibility
- Project Planning
- Deadline Management
- Multitasking
- Vision
- Mentoring
- Conflict Resolution
- Decision-Making
- Team Building
- Transparency
- Leading Cross-Functional Teams
- Influencing and Persuading Stakeholders
- Change Management
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- Regulatory Software (eCTD, Submission Tools)
- Data Analysis Tools
- Document Management Systems
- Audit Management Software
- CRM Tools
- Regulatory Policies
- International Regulations
Additionalinformation
Eligible to work in the United States without sponsorship., Student Member
Projects
Device and Development Plan, Developed and executed a strategic regulatory roadmap, guiding successful 510(k) submissions and product launch on Herculink Elite renal stent system, further coordinated into product development timelines and conducted validation activities to support regulatory submissions and ensure product safety and efficacy. Regulatory Response / Recall Notice Assessment, Assessed the impact of regulatory actions of a recall on product safety, quality, and market availability of Insulin injection with actionable recommendations to mitigate risks, improve regulatory compliance and enhance overall product lifecycle management. 510K and PMA Documentation Plan, Spearheaded a comprehensive 510(k) and PMA documentation in class project, showcasing expertise in regulatory submission requirements, technical writing proficiency, and diligent project management skills. EUMDR and Other International Regulatory affairs Documentation, Executed international regulatory project spanning EUMDR, TGA, Health Canada. Developed technical files adhering to EUMDR requirements like clinical evaluations, PMCF plans. Interpreted EUMDR guidelines for classifications, conformity assessments, QMS upgrades. Demonstrated global regulatory strategy, project management, regional compliance prowess.
Timeline
Post Market Surveillance & Regulatory Specialist
Thermofisher Scientific
12.2021 - 12.2022
Associate Post Market Surveillance & Regulatory Specialist
PPD
11.2019 - 12.2021
Master of Science - Regulatory Affairs & Services
St Cloud State University
Doctor Of Pharmacy -
Palamuru University
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