MEGHANA BHADARGE

857-***-**** Boston, MA ad4lym@r.postjobfree.com https://www.linkedin.com/in/meghana-bhadarge/ SUMMARY

A Professional with a robust skillset in quality and regulatory compliance across the pharmaceutical industry. Proven expertise in maintaining and enhancing Quality Management Systems (QMS), adept at leading compliance activities for Health Authority submissions and global regulatory adherence. Experience with compliance to align with ICH, GCP, and GMP guidelines. Have been involved in troubleshooting technical issues, authoring technical justifications, and contributing to process validation for pharmaceutical manufacturing site, to track record for growth, integrity, and innovation along with work skill improvement and continuous learning.

EDUCATION

Northeastern University Boston, MA Expected Jun 2024 Master of Science in Regulatory Affairs

University of Mumbai India Jan 2021

Master of Science in Pharmaceutical Quality Assurance University of Mumbai India Feb 2018

Bachelor of Pharmacy

WORK EXPERIENCE

AG Mednet Boston, MA Aug 2023-Jan 2024

Quality and Regulatory Compliance Intern

Executed tasks regarding Quality Management System (QMS) to adhere to the quality system regulations.

Assisted with training administration to comply with ISO and CFR requirements to achieve SOC 2 compliance.

Collaborated with cross functional teams such as Engineering, Trail Delivery, Customer Support to drive regulatory and quality compliance.

Supported Quality and Regulatory Compliance activities in validation, vendor audit, training, gap analysis and updating internal procedures and processes (reviewing database changes and access control) and maintained records in designated repositories. Freyr Global Solutions- Novartis Healthcare Pvt. Ltd - Global Drug Development Mumbai, India Mar 2021-Aug 2022 Executive Regulatory Affairs

Managed Health Authority submissions and global regulatory compliance for new drugs, including New Drug Application (NDA), Investigational New Drug (IND) Application, labeling and package insert reviews, indications, and registrations of innovative product in Cardiovascular portfolio.

Independently led compliance activities such as QSR (Quarterly Study Reports), Periodic Safety Update Reports (PSURs), post-approval changes, global CMC submissions, and global clinical trial applications (CTAs).

Performed reviews and drafted global clinical study protocols, Investigator Brochures, and eCTD dossiers in collaboration with team members for GCP compliance.

Maintained regulatory requirements and communicated registration needs along with data collection for archiving documents using Dragon software.

Conducted gap analyses and recommended process for continuous improvement. AdvanzPharma Mumbai, India May 2020-Feb 2021

Technical Support Executive- Quality Assurance

Supported and collaborated with stakeholders for manufacturing activities to troubleshoot drug product technical issues and ensure QA compliance with GxP documentation and record management system.

Authored, reviewed, and approved technical documentation, RFIs, technical reports, cover letter, and labels/packaging inserts for US and EU marketed drug products.

Contributed to technical transfer and process validation activities, including authoring and reviewing of drug product Batch Manufacturing Records

(BMRs) and Process Validation Records (PVR).

Managed Quality Management System (QMS) activities such as Change Controls, Deviations and Corrective and Preventive Actions (CAPAs) using Trackwise software for tracking the product status and process improvement.

Participated in audits, prepared audit responses, and ensured compliance with quality as per cGMP and GLP guidelines. SKILLS

Technical: Risk Management Regulatory Compliance Regulatory Affairs Quality Assurance Project Management Regulatory Writing

Soft skills: Leadership Teamwork Critical Thinking Organizational skills Verbal/Written Communication Time management

Software: Trackwise RIM system Dragon JIRA TortoiseSVN Repository Microsoft office PowerPoint Word Excel Adobe Acrobat Outlook ACADEMIC PROJECTS

Northeastern University Feb 2024

Designed an Informed Consent Form for an ongoing phase 3 study as a team project.

Conducted a thorough review and presented research on studies conducted for Sotorasib by referencing multidisciplinary review from Drugs@FDA

Drafting IND and NDA documents as per eCTD format in compliance with 21 CFR 312. Mumbai University Jan 2021

Formulated Osmotically controlled drug delivery system (OCDDS) with an approach to formulate controlled porosity osmotic pump (CPOP) minitablets and immediate release tablet primed in a capsule (i.e. Tab in Cap) for better compliance with reduced dosing frequency.

Manufactured nanofiber based sanitary napkin for women’s hygiene with better absorbency and for non-biodegradable free environment. PUBLICATION

Bhadarge Meghana*, Dhas Umesh, Shirode Abhay, Kadam Vilasrao. Electrospinning Nanotechnology- A Robust Method for Preparation of Nanofibers for Medicinal and Pharmaceutical Application. Asian Journal of Pharmaceutical Research and Development.8(3), 176-184. 2020. https://www.ajprd.com/index.php/journal/article/view/747