Gayani Yasoma Wellana Gamage
Avondale Auckland,New Zealand
Summary
Reliable Manager demonstrating high level of ownership and initiative. Possessing exceptional work ethic and desire to go above and beyond to exceed company expectations. Offering knack for building productive working relationships. Successful in fast-paced, deadline-driven environments to manage goals and team development. History of thriving in team-oriented environments. Results-driven Manager known for high productivity and efficient task completion. Specialize in strategic planning, and operational improvement. Excel in communication, problem-solving, and adaptability, ensuring seamless project execution and team cohesion. Proactive and versatile professional with a dedication to quickly adapting to new challenges. Strong problem-solving abilities and a proven track record of fostering strong relationships with clients and team members. Focused on supporting team success and achieving positive results.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Manager Quality Regulatory affairs & Pharmacovigilance manager
Novo Nordisk (Lanka) Pvt Ltd
07.2019 - 01.2023
- Key Responsibilities.
- To secure regulatory approvals of new products and devices in due time, for Novo Nordisk products in the affiliates, ensure the maintenance of PV systems in compliance with global and local requirements.
- Delegated (from management) responsibility for the implementation of Novo Nordisk Quality Management System (QMS) in the affiliate, ensuring product quality and hereby focusing on business critical issues that may have an impact on license to operate and inspection readiness.
- Ensure that the QMS in the affiliate is maintained and in compliance with Novo Nordisk requirements and external requirements. Train and communicate the QMS throughout the local affiliate organization. Act as Quality Management Representative for Quality Issues in the country.
- Created monthly reports for senior management summarizing regulatory quality and pharmacovigilance operational metrics.
- Conducted regular meetings with distributors to discuss progress and identify areas of improvement.
- Provide inputs for process improvements to ensure efficient workflow throughout the organization.
- Maintained up-to-date records of product lifecycle and quality system.
- Handling regulatory information using Regulatory Information Management Tools (RIMs)
- Validate pre and post-approval activities align with health authority requirements
- Asses of global regulatory requirements to the country requirements
- Handling overall quality requirements in pharmaceutical supply chain storage marketing and sales
- Preparation of Quality Management Review (QMR) reports
- Act as the quality management representative in the affiliate.
- Monitoring change control in the overall process
- Monitor GMP GDP / GxP clearance requirements and maintain compliance
- Experience in Audit (Regional and global internal audits and supplier audits)
- Fair knowledge of Global Pharmacovigilance requirements
- Customers complain handling pharmaceuticals
- Familiar with NovoGlow, CCGLOW and PV compliance processes
Manager DRA for Novartis Pharma Services
A. Baur & Co Ltd
Colombo, Sri Lanaka
01.2016 - 07.2019
- Coordinated with government agencies for timely product and variation approvals.
- Compiled monthly summaries on product registration and lifecycle status for regional office
- Reviewed marketing materials for regulatory compliance
- Collaborated with departments ensuring smooth operation flows
Manager - Regulatory Affairs
Darley Butler & Co Ltd
Colombo 10
07.2009 - 12.2015
- Coordinated with government agencies for timely product and variation approvals for Medicines, Medical devices, and cosmetics.
- Compiled monthly summaries on product registration and lifecycle status for manufacturers.
Regulatory Affairs Officer
Swiss Biogenics Pvt Ltd
Colombo 01
07.2006 - 01.2008
- Coordinated with government agencies for timely product and variation approvals for Medicines, Medical devices, and cosmetics.
- Compiled monthly summaries on product registration and lifecycle status for manufacturers.
Pharmacists (Executive)
Cargills Ceylon Ltd
06.2005 - 07.2006
- Managed pharmacy store inventories efficiently
- Dispense medication.
- Provided guidance on pharmaceutical treatment process, doses, and side effects.
- Advised patients on medication usage
Executive – Regulatory Affairs
Mansel Ceylon Ltd
11.2003 - 02.2005
- Coordinated with government agencies for timely product and variation approvals for Medicines, Medical devices, and cosmetics.
- Compiled monthly summaries on product registration and lifecycle status for manufacturers.
Education
Master of Science - Health Sciences
Eastern Institute of Technology
Auckland, NZ09-2024
Master Of Business Administration -
Cardiff Metropolitan University Wales Through The ICBT Campus
Colombo, Sri Lanka05-2017
Postgraduate Diploma - Business Management
Faculty of Graduate Studies University of Colombo
Sri Lanka01.2015
Executive Diploma - Business Management
Faculty of Graduate Studies University of Colombo
Sri Lanka01.2012
Diploma - International Business
Institute of Human Resource Advancement University of Colombo
Sri Lanka01.2009
Diploma - Advance English for Administration and Academic Purposes
University of Colombo
Sri Lanka01.2006
Diploma - Pharmacy
Faculty of Medicine The University of Colombo
Sri Lanka05-2003
Skills
- Willing to work with a compliance mindset
- Team player
- Sociable with a pleasing personality, adaptable, loyal and punctual
- Analytical skills combined with a proactive mindset focused and deliver the job on time
- Communication & Negotiation Skills
- Smart, quick learner
- Pro-active with self-development and learning
- Hard working & willing to learn, industry insights Intermediate Trello user (Project Management Tool)
- Solutions & plans for situational incidents to avoid or minimize the impact on the business
- Management of stakeholder relationship's ability to take initiative and work independently with minimum involvement if required
- Innovation management
- Complex Problem-Solving
- Negotiation
- Cross-Functional Teamwork
- Project Management
References
REFEREES 1. 2. S. Selva Niroshan General Manager (Australia and New Zealand) Email: ssnirosahn@gmail.com Accord Healthcare Phone: +61 410 175 526 Sanjeewa Jayaratne. Marketing CE & Key Accounts manager Sri Lanka & Maldives and Commercial Lead Maldives Novo Nordisk Lanka Pvt Ltd. Email: sanjeevjayaratna@gmail.com Phone: +94 77 313 3779 Teulia Alaalatoa | 021 000 0000 |teulia.alaalatoawork@email.com Gayanigamage78@gmail.com/ 0220756780
Affiliations
Active a life member of the Pharmaceutical Society of Sri Lanka. Blood donor- Group B+ (In the year - 2003,2004, 2007,2010,2014).
Accomplishments
- Successful completion of product brnad name change projects, Prodcut manufacturing site changes, align with packing material cration and and approval of Novo Nordisk products in Sri Lanka and Maldives
- Sucessful competion of Aloconm Novartis merge in Sri Lankan arket
Certification
- Registered Pharmacist in Sri Lanka Medical Council
Languages
English
Professional
Sinhalees
Full Professional
References
References available upon request.
Timeline
Manager Quality Regulatory affairs & Pharmacovigilance manager
Novo Nordisk (Lanka) Pvt Ltd
07.2019 - 01.2023
Manager DRA for Novartis Pharma Services
A. Baur & Co Ltd
01.2016 - 07.2019
Manager - Regulatory Affairs
Darley Butler & Co Ltd
07.2009 - 12.2015
Regulatory Affairs Officer
Swiss Biogenics Pvt Ltd
07.2006 - 01.2008
Pharmacists (Executive)
Cargills Ceylon Ltd
06.2005 - 07.2006
Executive – Regulatory Affairs
Mansel Ceylon Ltd
11.2003 - 02.2005
Master of Science - Health Sciences
Eastern Institute of Technology
Master Of Business Administration -
Cardiff Metropolitan University Wales Through The ICBT Campus
Postgraduate Diploma - Business Management
Faculty of Graduate Studies University of Colombo
Executive Diploma - Business Management
Faculty of Graduate Studies University of Colombo
Diploma - International Business
Institute of Human Resource Advancement University of Colombo
Diploma - Advance English for Administration and Academic Purposes
University of Colombo
Diploma - Pharmacy
Faculty of Medicine The University of Colombo
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