Summary
Overview
Work History
Education
Skills
Certification
Personal Information
Awards
Extracurricular Activities
Training
Disclaimer
Software
Timeline
Generic

BHAKTI ASHTAKAR

Regulatory Affairs Specialist
Pune

Summary

Proficient in Pharmacy & Medical Device 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.

Overview

7
7
years of professional experience
6
6
years of post-secondary education
5
5
Certifications
3
3
Languages

Work History

Regulatory Affairs Specialist

Tata Elxsi
5 2022
  • Handling 45+-member team, Technical expert in DHF
  • Prepared robotic assisted system for automated internal project process
  • Experience in Project management related activities such as effort estimation, cost sheet, project proposal, client interaction for proposal and SoW creation and finalization, creation WON
  • Experience on regulatory submission of FDA and other regulatory submissions (Pre- submissions, IDE, 510(k), PMA, Technical Files/Design Dossier)
  • Experience in DHF remediation of Catheters, Guidewires, Myringotomy, Stents, Laser lithotripsy, Respiratory, Endoscopic product along with accessories for ENT, GI, Orthopedics, Gynecology
  • Handson experience on CSV, DxP, Software validation, complaints handling and MDR reporting
  • Performed risk management activities PFMEA, DFMEA and Usability FMEA for medical device
  • Experience in performing QMS related activities
  • Experience of preparing Clinical Evaluation Plan and Clinical Evaluation Report
  • Familiar and Experience on as 21 CFR 820, ISO 13485, ISO 14971,MDSAP, IEC 62366 ISO 14155, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820,21 CFR part 11,21 CFR 803, EUMDR and product specific industry standards
  • Handled software like Agile, Bartender for labeling, Cognition cockpit, MS project for project planning.

Research Officer

Rubicon RESEARCH Pvt Ltd.
  • Performed method development and validation for Solid oral Dosage form in terms of Assay, Related substances, Dissolution method and cleaning method also Preparation and review of Stability protocols, stability reports, IPS, FPS, and MOA etc
  • Reviewed of DMF, Raw material Specification, manufacturing Documents and Packaging Documents etc
  • Preparation of APR/PQR, annual reports for post marketing, temperature excursion reports and protocol as well as Preparation of AMT reports and prior review
  • Along with technology transfer activities including partial validation and preparation documents required for same
  • Experience and knowledge of operate instrument like: UPLC (WATERS), HPLC (SHIMADZU, WATERS, AGILENT, DIONEX), UV spectrophotometer, Dissolution apparatus (ELECTROLAB , LAB INDIA), Karl fisher titrator( Lab India).

Associate Engineer

IZiel Healthcare
02.2020 - 05.2022
  • Knowledge of guidelines & regulations pertaining to regulatory submissions for EU for medical device such as 21 CFR 820, ISO 13485, ISO 14971, IEC 62366 etc
  • Experience in EU-MDR, MDD
  • Experience in performing QMS related activities
  • Experience of preparation Clinical Evaluation Plan and Clinical Evaluation Report
  • Performed risk management activities PFMEA, DFMEA and Usability FMEA for medical device
  • Prepared product supporting documentation such MPI’s, LHR’s PLQIA, FLQIA, CQD, Label specs, Labels, Quality audit checklist
  • Performed Gap assessment for products
  • Handled the software like Agile, Bartender for labeling, Cognition cockpit.

Regulatory Affairs Specialist

Sciformix Technologies Pvt. Ltd
08.2015 - 06.2019
  • Knowledge of guidelines & regulations pertaining to regulatory submissions for US, EU & Other markets of formulation, API and medical device
  • Experience in preparation of dossier and review of module 3 sections which are going to submit in regulatory submission
  • Experience in EU-MDR, MDD
  • Experience in Medical device Accelerated stability study reporting
  • Performed eLIMS study Approval
  • Report writing for APR/PQR, annual reports for post marketing, temperature excursion reports and protocol writing as well as AMT report writing and performed review reports
  • Coordinate with various departments like R&D, QC, QA and formulation to prepare the documents for regulatory submission
  • Handling GSS (Global Specification System) for updates, Review and routes in Software ENOVIA Matrix, ETQ RELIANCE and TRU
  • Handled the software like labvantage, IBM congons connection, Docspace, Oracle and SAP, Intralinks, AWS, Docspace Minitab, Compliance wire etc
  • Acquired knowledge by working on various projects and presentations
  • Performed training coordination for organization as well with in team and project coordination/management activity
  • Knowledge of cGMP and concept of quality assurance
  • Technical proficiency with Microsoft office suit of application, document management and publishing tools
  • Dealing with clients for requirements tracker of the post marketed products
  • SOPs Preparation and review.

Education

M.D. - Part Time_Biotech

Krishna Vishwa Vidyapeeth (Karad)
Maharashtra
01.2023 - 01.2027

Master of Science - Pharmaceutical Chemistry

Sinhagad Institute of Pharmaceutical Sciences, Lonavala (Pune)
08.2011 - 04.2013

Bachelor of Pharmaceutical Sciences (B.Pharm) - undefined

Dr. L. H. Hiranandani College of Pharmacy, Ulhasnagar

Higher Secondary Certificate - undefined

Pragati college of Arts, commerce and Science, Dombivli (E) Maharashtra

Secondary School Certificate - undefined

Tilak Nagar Vidya Mandir, Dombivli (East), Maharashtra

Skills

  • Global Regulatory Compliance

  • Regulatory Submissions

  • Project Management

  • Technical Documentation

  • Risk Management

  • Complaint Handling

Certification

Marketing Foundations: Market Research; Jul 2019

Personal Information

  • Date of Birth: 03/21/90
  • Gender: Female
  • Marital Status: Married

Awards

  • Steller Performance Award
  • 5 Extra Mile Awards
  • 2 Customer Appreciation Awards

Extracurricular Activities

Received Maharashtra State Certificate in Information Technology (MS-CIT) Received Certificate of Proficiency for 1st Prize in AD-MAD Show during third year B.Pharm Received 3rd price for inter collegiate skit competition on NATIONAL PHARMACY WEEK 2009

Training

  • Recent Trend in Pharmacy and Future Scenario; 15-16 Feb 2012
  • Industrial Application of In-Vitro In-Vivo correlation (IVIVC); 10th& 11th March 2012
  • Application of Statistics in Designing Pharmaceutical Experiments; 2nd March 2012
  • M. Pharm thesis project, GETZ PHARMA RESEARCH PVT. LTD., AMBERNATH, 6 months, Performed routine analysis (Assay, Dissolution, CU, Related Substances etc.). Performed Comparison Dissolution Studies.
  • One-month industrial training, UNICHEM LABORATORIES LTD., JOGESHWARI, MUMBAI, 1 month, Work related to development of various formulations (Solid dosage forms).

Disclaimer

I hereby declare that all the information provided here is as per the best of my knowledge.

Software

Bartender

Labventage

Docusign

Cognision Cockpit

Agile

Minitab

Timeline

M.D. - Part Time_Biotech

Krishna Vishwa Vidyapeeth (Karad)
01.2023 - 01.2027

Associate Engineer

IZiel Healthcare
02.2020 - 05.2022

Regulatory Affairs Specialist

Sciformix Technologies Pvt. Ltd
08.2015 - 06.2019

Master of Science - Pharmaceutical Chemistry

Sinhagad Institute of Pharmaceutical Sciences, Lonavala (Pune)
08.2011 - 04.2013

Regulatory Affairs Specialist

Tata Elxsi
5 2022

Research Officer

Rubicon RESEARCH Pvt Ltd.

Bachelor of Pharmaceutical Sciences (B.Pharm) - undefined

Dr. L. H. Hiranandani College of Pharmacy, Ulhasnagar

Higher Secondary Certificate - undefined

Pragati college of Arts, commerce and Science, Dombivli (E) Maharashtra

Secondary School Certificate - undefined

Tilak Nagar Vidya Mandir, Dombivli (East), Maharashtra

Similar Profiles

CREATE PROFILE
BHAKTI ASHTAKARRegulatory Affairs Specialist