Nadeesha Wijwardana
Leander,TX
Summary
Accomplished Manager in Drug Regulatory Affairs with a proven track record at Sanofi Lanka Limited, adept in regulatory compliance and clear communication. Excelled in leadership roles, enhancing customer satisfaction and loyalty, and demonstrated expertise in policy development and workforce management. Skilled in navigating organizational changes and increasing efficiency.
Overview
13
13
years of professional experience
Work History
Manager Drug Regulatory Affairs
Sanofi Lanka Limited
, Sri Lanka
09.2015 - 12.2017
- Develop regulatory strategy and provide regulatory expertise within project/product teams for product under development and marketed products
- Interface with various projects/teams
- Coordinate dossier and briefing package preparation according to the plans
- Ensure optimal support to key stakeholders to deliver on time high quality dossiers in compliance with health authority requirements
- Updating internal systems regularly
- Carried out all the required communication with the local affiliate, zone and region
- Provided leadership during times of organizational change or crisis situations.
- Developed and implemented strategies to increase customer satisfaction and loyalty.
Manager- Regulatory Affairs
Alaris Lanka (Pvt) Ltd
, Sri Lanka
02.2011 - 10.2015
- Handling the registration matters related to Drugs, Devices & Cosmetics and Following up with Cosmetics, Drugs and Devices Authority (CDDA)
- Handling correspondences and communicating with overseas principals
- Provide technical advice & assistance related to all regulatory aspects
- Providing administrative support to designated areas/departments as required by upper management
- Maintaining effective filing & record management system
- Preparation of reports for meetings
- Participate in staff meetings and providing feedback on recommendations for improvements
Executive - Regulatory Affairs
Pan Pharma Pharma (Pvt) ltd
, Sri Lanka
11.2008 - 01.2011
- Handling the drug registrations
- Following up with Cosmetics, Drugs and Devices Authority (CDDA)
- Handling correspondences (Drafting letters / Maintaining filings / communicating with foreign Principals)
- Attending tender openings
- Maintaining the Attendance / Leave register and checking the Daily Call Reports of the Sales Staff
Administration assistant
Apex Pharmaceuticals (Pvt) Ltd
06.2006 - 01.2007
- All necessary administration supports
- Responsible for administration tasks and duties within the office and acting as an administration link between the sub stores
- Managing record-keeping functions and activities to ensure fair legal administration of human resources
- Personal Files
- Managing pre-approval of staff over time
- Sick leave
- Any additional human resources related issues
- Sales and stock statistics for feeding the computer
- Preparation of monthly sales statements
- Area –wise budget statement
- Regulatory affairs
- New drug registrations, Preparing Dossiers
Administration assistant cum assistant pharmacist
Health Guard Pharmacy (Pvt) Ltd
01.2005 - 01.2006
- Maintaining Leave records
- Maintaining stock inventory and new purchases
- Dispensing medicines
- Preparing staff over time
Education
MBA - Business Management
Cardiff Metropolitan University- Wales (London)
Through ICBT Campus Colombo01.2023
Some College (No Degree) - Diploma in Electronic Medical Record Management
Ashworth College
Norcross, GA02-2025
GCE A/L Examination - Science
Vishaka Balika Vidyalaya
Bandarawela, Sri Lanka01.2000
GCE O/L Examination -
Vishaka Balika Vidyalaya
Bandarawela, Sri Lanka01.1997
Advanced Diploma - Business Management
Management University College Dublin
Sri LankaDiploma - Business Management
IDM Business Studies Division
Sri LankaDiploma - Computer Studies
Royal Institute
Sri LankaSkills
- Marketing
- Performance management
- Workforce management
- Regulatory compliance
- Task delegation
- Policy and procedure development
- Clear communication
- Budget control
- Verbal and written communication
Timeline
Manager Drug Regulatory Affairs
Sanofi Lanka Limited
09.2015 - 12.2017
Manager- Regulatory Affairs
Alaris Lanka (Pvt) Ltd
02.2011 - 10.2015
Executive - Regulatory Affairs
Pan Pharma Pharma (Pvt) ltd
11.2008 - 01.2011
Administration assistant
Apex Pharmaceuticals (Pvt) Ltd
06.2006 - 01.2007
Administration assistant cum assistant pharmacist
Health Guard Pharmacy (Pvt) Ltd
01.2005 - 01.2006
MBA - Business Management
Cardiff Metropolitan University- Wales (London)
Some College (No Degree) - Diploma in Electronic Medical Record Management
Ashworth College
GCE A/L Examination - Science
Vishaka Balika Vidyalaya
GCE O/L Examination -
Vishaka Balika Vidyalaya
Advanced Diploma - Business Management
Management University College Dublin
Diploma - Business Management
IDM Business Studies Division
Diploma - Computer Studies
Royal Institute
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