REGULATORY AFFAIRS EXECUTIVE
World leading manufacturer & exporter of premium gloves products
Participates in the development and implementation of the regulatory strategy:
Compiles information and data pertaining to regulatory and project requirements.
Assembles a regulatory file/dossier:
Coordinates acquisition of all applicable data.
Drafts and submits the regulatory file.
Conducts and reviews regulatory monitoring of approved products:
Assists and supports in-house teams.
Ensures regulatory compliance.
Evaluates the effects of an amendment/change.
Takes appropriate regulatory actions.
SOPs to define the requirements for regulatory submissions.
Assisting in customer complaint handling and to ensure timely completion of investigation, documentation and preparing complaint report.
Provide the regulatory reviews of customer complaints and define the regulatory reportability.
Review labelling and labels for compliance with regulatory requirements.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Responsible for timely registration of the facility.
Timely compile materials for license renewals, updates and registrations
Undertake ad-hoc regulatory projects / duties as required
Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree
WRP Asia Pacific Sdn Bhd is in the business of providing innovative solutions for protection and contamination control needs of its customers. It is a leading manufacturer of gloves for medical, dental, radiation protection, food services, pharmaceutical, critical environments and industrial applications.
Supporting a distribution network around the world, WRP's sales and marketing offices are located in Europe, USA, Asia Pacific and Central America.
WRP is expanding to meet the increasing demand of its global partners-customers and distributors. To-date, it has a staff force of more than 3,500 around the world.
We seek dynamic and committed individuals to be part of WRP team.
Additional Company Information
2001 - 5000 Employees
Polymer / Plastic / Rubber / Tyres
Benefits & Others
Medical, Parking, Regular hours, Mondays - Fridays, Business (e.g. Shirts), Attendance allowance, Night shift allowance