Swati Pudat
Leon,Spain
Summary
Self-motivated Regulatory Affairs Associate holding 11 years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Associate
Leon Farma
Leon
04.2024 - 07.2024
- Managed deficiency letter submission for international regulatory affairs related to MENA countries
- Managed Variation submission to MENA market
- Responded to Due diligence for new product submission
- Managed Module 1 Documents submission for different countries
- Supported Clients for new dossier submission and life cycle management
- Supported for Site and product registration renewal procedure
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
- Received, researched and resolved Client inquiries.
Senior Consultant
Continuum
02.2022 - 03.2024
- Managed post approval submission for US market
- Authored CMC sections related to Dossier
- Managed and tracked regulatory Data repository
- Compilation and filling of dossiers (Module 1, 2 and 3) for USFDA, Health Canada for Liquids, Injectable, and Solid dosage form
- Reviewed various study reports for submission purpose
- Review and assessment of changes with respect Regulatory impact on NDAs
- Managed annual submission package
- Deficiencies handling and preparing response to Health Authority Agencies
- Hands on various software like Track wise, symphony, SAP etc
- Evaluated clients' needs and created plan of action to provide solutions.
- Increased client satisfaction by providing tailored consulting services and effective problem-solving strategies.
- Built strong relationships with clients through consistent communication and proactive problem-solving efforts.
- Prioritized projects and project tasks depending upon key milestones and deadline dates.
Senior Executive
Jamp Pharma
10.2020 - 12.2021
- Managed submission of ANDS and supplement for solid oral dosage form and parenteral dosage form in eCTD format to Health Canada
- Prepared pre-NDS meeting request and pre-NDS package
- Prepared due diligence of dossier as per Health Canada requirement
- Managed third party dossier review and identifying submission risks and opportunities
- Evaluated change control assessment
- Handled deficiencies by Health Canada in context of ANDS and SANDS
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Managed communication and coordination with cross functional team of Contract Manufacturer (CMO)
- Successfully managed collaboration with publishing teams to assure efficient delivery of end-to-end submission output to project timelines
- Handled eCTD software; Pharmaready
Senior Executive
Zydus Cadila Health Care
Ahmedabad, Gujarat
07.2017 - 09.2020
- Supported in US Injectable regulatory submission
- Change control evaluation related to regulatory impact
- Managed compilation and filling of dossiers (Module 3) for USFDA, EU etc.
- Reviewed ANDA documents for submission and commercial Batches as per ICH Requirements
- Successful co-ordination with various departments for scientific data
- Managed annual submission package
- Actively Participated in trainings/presentations to cross-functional departments
- Updating of database related site registration and site approval
- Regulatory support to various departments
- Supported for site renewal & grant license application preparation for Japan, o Philippines, o Canada and o Latin America
- Active participation in USFDA and MHRA audits
Executive
Micro Labs Private
07.2013 - 03.2017
- Drafting, Review and approval of documents for regulatory submission
- Receipt and review of stability study protocol
- Support in USFDA & MHRA audit preparation – sterile/solids facilities
- Effective control on R&D documentation
- Coordinated and communicated for DMF
- Review and finalization of specification
- Co-ordination with RA, FD, AD and production department
- Contributed to increase quality standards by 50% in R&D.
Education
M.Pharm - Pharmaceutics
Bhagwan College of Pharmacy
INDIA 05.2012
Skills
- Global Regulatory Compliance
- Regulatory Documentation Mastery
- Regulatory Audits
- Teamwork and Collaboration
- Problem-solving abilities
- Attention to Detail
- Adaptability
- Interpersonal Skills
- Continuous Improvement
- Electronic Common Technical Document
Languages
English
Bilingual or Proficient (C2)
Spanish
Beginner (A1)
Additional Information
Professional Achievements
- Served as one point contact for complete regulatory function of a sterile facility
- Handled all documents for Complex Liposomal injection
- Outperformed the responsibility as a reviewer for a complex product’s regulatory Submission
- Involved in site master file preparation for R&D
- Reviewed Audit Trails of analytical instruments
Audit Involvement
- Active Participant in USFDA & MHRA audit of oral/parenteral facilities
- Preparation for regulatory audits dossier
- Preparation of Audit compliance report based on observations
- Successfully justified a role of AUDIT SCRIBE in the USFDA inspection
- Preparation of facility presentations for Audit
Personnel Attributes
- Sound technical knowledge
- Comprehensive problem-solving abilities
- Excellent verbal & written communication
- Ability to deal with people diplomatically
- Team Spirit
- Visible energy level
- Self-development and achievement orientation
Timeline
Regulatory Affairs Associate
Leon Farma
04.2024 - 07.2024
Senior Consultant
Continuum
02.2022 - 03.2024
Senior Executive
Jamp Pharma
10.2020 - 12.2021
Senior Executive
Zydus Cadila Health Care
07.2017 - 09.2020
Executive
Micro Labs Private
07.2013 - 03.2017
M.Pharm - Pharmaceutics
Bhagwan College of Pharmacy