TANVI MANE
Chantilly,VA
Summary
Sr. Regulatory Affairs professional with 2 years of experience in Regulatory Management and safety activities of generics, brand and OTC Monograph products. Faced and handled FDA's Post marketing Adverse Drug Experience (PADE) audit with zero observations. Methodical and objective with good organization and sound critical thinking and problem-solving abilities.
Overview
8
8
years of professional experience
Work History
Senior Regulatory Affairs Associate
Granules Pharmaceuticals Inc
07.2023 - Current
- Managed ANDAs post-approval activities by submitting notifiable changes, original amendments, and supplements like CBE-0 and CBE-30 and following up with regulatory agencies.
- Supported new ANDA filings in eCTD format by authoring module 1 and reviewing CMC sections as assigned by regulatory manager.
- Worked on building, reviewing, and submitting electronic submissions including Annual Reports, PADERs, and various other maintenance documents routinely to FDA utilizing FDA-ESG gateway.
- Drafted and revised product labelling like medication guides and labels in MS Word, Adobe PDF, and annotated (side-by-side version) as per FDA guidance/update and GPI SOPs.
- Worked closely with artwork vendors, packaging sites, marketing team to review and implement labeling changes using GlobalVision.
- Assisted with new/renewal applications for 32+ individual state licenses and controlled substance licenses.
- Authored, and revised Regulatory SOPs like Pharmacovigilance Program and Recall SOPs.
- Collaborated cross-functionally and trained 20 associates
- Contributed to product sales of 20 generic products in Puerto Rico via tasks like product registration, label review, registration process, and keep up with preparation and submittal to Puerto Rican regulatory agency and designated representative.
Regulatory Affairs Associate
Granules Pharmaceuticals Inc.
08.2021 - 07.2023
- Handled and triaged market complaints like adverse drug reactions, product quality complaints, medical inquiries.
- Authored Annual reports, internal annual product quality reports (APQR), and trending reports on yearly basis.
- Authored, revised Regulatory SOPs like Pharmacovigilance Program and Recall SOPs. Collaborated cross-functionally and trained 20 associates.
- Compiled and reviewed Safety Data Exchange Agreements and Quality agreements for both domestic and international vendors.
- Prepared, reviewed, and submitted Field Alert Reports (FARs) for qualifying company products to FDA district office.
- Utilized Clinevo to review ICSRs for their validity and submission following US FDA timelines.
- Assisted regulatory manager in tracking changes to product life-cycle management by initiating and approving change controls.
- Responsible for tracking and notifying of FDA Warning Letters issuance to company's vendors, API manufacturers.
- Managed and headed meetings with 3PL to discuss business license renewals, gap analysis reports, CalRecycle Project for company products.
- Communicated with third-party consultants to ensure timely submission of new, annual, and quarterly WAC reports, complying with Drug price transparency laws for 50 US States.
- Represented company in REMS sponsor meetings with REMS service providers for 8+ months and looked after REMS DMF updates.
Regulatory & Quality Analyst Intern
TVP Health
04.2021 - 06.2021
- Worked in Qualio to establish robust Quality Management System (QMS) for Class II device as per 21 CFR 11
- Implemented various SOPs, recommended revisions, and made them effective in Qualio.
- Addressed non-conformance issues, pausing production to correct errors.
- Experience and strong knowledge of 510(k) preparation
- Prepared and compiled Design History File (DHF) while collaborating with engineering & quality team.
- Supported quality team by capturing and resolving non-conformances, deviations, complaints, and CAPA implementation.
- Drafted regulatory compliance report to market device in nine target countries for EUA submission.
Strategy Analyst Intern
StarlingBrook Leadership Consulting
04.2020 - 06.2020
- Analyzed target market and formulated competitive strategies for scaling up services of company.
- Advised on risk mitigation strategies to minimize potential threats to the company's long-term stability and growth prospects.
- Boosted firm's website traffic to 5000 visitors per month by collaborating with web developers to redesign website.
- Performed competitive analysis of other Canadian firms concerning market strategy & digital content.
- Enhanced overall business strategy by conducting thorough market research and competitor analysis.
Drug Safety Associate
Tata Consultancy Services
06.2017 - 10.2018
- Managed Pharmacovigilance activities of 2 large global clients by performing case processing of ICSRs & expedited
- SUSAR reports in Roche global safety database
- Utilized clinical judgment in coding adverse events and medical history in MedDRA using ArisG database
- Prepared high-quality medical narrative using ARIS manual including report source, medical history, events
- Conducted significant & non-significant Data Correction and reconciliation activities
- Initiated query process for clinical and RAVE studies to get clarification on various details of clinical cases.
- Improved patient safety by accurately reviewing and processing adverse event reports.
- Supported preparation of periodic safety update reports, showcasing attention to detail and commitment to accurate reporting.
Quality Assurance Intern
Maneesh Pharmaceuticals
05.2016 - 06.2016
- Assisted in developing Standard Operating Procedure (SOPs) for manufacturing process of solid dosages
- Reviewed and executed GMP batch documentation under the supervision of QA Manager.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA07.2021
Bachelor of Science - Pharmacy
Mumbai University
Mumbai, India03.2017
Skills
Regulatory & technical skills:
- Detail-oriented with excellent written, organization, and communication skills
- Conversant with: eCTD format submission, CMC sections, Clinical & Non-clinical, IND, and NDA submission requirements
- eCTD format submission: check/add bookmarks, insert hyperlink text, check and comply with document properties, Lorenz eValidator generator
- Emergency Use Authorization regulations, FDA Labeling
- MS Word, MS Excel, MS Outlook & PowerPoint, Adobe Acrobat, Qualio, ArisGlobal, CITRIX
- Familiar with GlobalVision, Clinevo, eCTD tools, medical Coding, MedDRA, ICD-9/10, ArisG, IRT, DRT, AgXchange
- Product Lifecycle Management
- Project Management, teamwork
- Labeling Compliance
Timeline
Senior Regulatory Affairs Associate
Granules Pharmaceuticals Inc
07.2023 - Current
Regulatory Affairs Associate
Granules Pharmaceuticals Inc.
08.2021 - 07.2023
Regulatory & Quality Analyst Intern
TVP Health
04.2021 - 06.2021
Strategy Analyst Intern
StarlingBrook Leadership Consulting
04.2020 - 06.2020
Drug Safety Associate
Tata Consultancy Services
06.2017 - 10.2018
Quality Assurance Intern
Maneesh Pharmaceuticals
05.2016 - 06.2016
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Pharmacy
Mumbai University
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