Akshay Patil
Buldhana
Summary
To pursue a successful, challenging and exciting career while dispensing my maximum potential to the benefit of the organization and at the same time complementing my passion for learning.
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
4
4
years of professional experience
Work History
Regulatory Affairs Officer
Abil Chempharma Pvt. Ltd.
Mumbai
03.2023 - Current
- Preparation of dossier in CTD, ACTD and country specific formats.
- Collaborated with cross-functional teams such as Quality Assurance, Manufacturing, Marketing. to ensure compliance with relevant regulations.
- Assisted in the preparation of responses to queries from regulatory agencies concerning product registration applications.
- Prepared technical documents including Summary Technical Documents, Clinical Evaluation Reports and Design Dossier.
- Ensured timely submission of annual reports required under various jurisdictions.
- Provided support during inspections conducted by Regulatory Authorities at the organization's facilities.
- Worked with regulatory bodies to negotiate filings, complete applications and report changes.
- Provided regulatory guidance and advice to the organization on applicable regulations.
- Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics.
- Collaborated with cross-functional teams to interpret and communicate new and revised laws.
Quality Assurance Officer
FDC Ltd.
03.2021 - 02.2023
- Working in QMS, handling Change Control section.
- Developed and implemented quality assurance standards for all processes.
- Monitored compliance with established policies, procedures, and regulations.
- Conducted regular audits to ensure product quality and safety.
- Investigated customer complaints regarding product quality and ensured corrective action was taken promptly.
- And many more.
Medical Coder
Episource
07.2020 - 03.2021
- Prescription analysis and coding
Education
B.Pharmacy -
Rajarshi Shahu College of Pharmacy
Buldhana01.2019
Skills
- Communication
- Organization
- Teamwork
- Regulation Compliance
- Technical Writing
- Product Documentation
- Data entry
- Attention to detail
- Inspections
Affiliations
- General Secretary of college for year 2018-19.
- Captain of college university cricket team.
- Handled many cultural events.
Timeline
Regulatory Affairs Officer
Abil Chempharma Pvt. Ltd.
03.2023 - Current
Quality Assurance Officer
FDC Ltd.
03.2021 - 02.2023
Medical Coder
Episource
07.2020 - 03.2021
B.Pharmacy -
Rajarshi Shahu College of Pharmacy
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