Agensi Pekerjaan Pasona Sdn Bhd Vacancies Regulatory Affairs Exe (Medicine/Medical Device) @ Damansara Heights [REF: CW]

Agensi Pekerjaan Pasona Sdn Bhd is looking for new potential candidates to fill in for Regulatory Affairs Exe (Medicine/Medical Device) @ Damansara Heights [REF: CW] position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.

Job Description

Your Job Responsibilities:-
  • Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
  • Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
  • Review technical dossier of new products and prepare additional documents where necessary.
  • In-charge with the timely approval and renewal of product licences, company licenses, pre- and post-approval variations, permits and other applications.
  • Provide appropriate solutions for compliance issues.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
  • Keep updated with local Health Authority regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
  • Maintain a current awareness of the regulatory requirements for the marketing of medicinal products in Malaysia and general legislation and guidelines.
Requirements:-
  • Minimum Diploma/Bachelor’s Degree in any related field
  • At least 2 – 4 years of related working experience
  • Experienced of registering of drug, medicine/medical device.
  • Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
  • Required language: Mandarin, English, Bahasa Malaysia (to liaise with clients and external parties)
Addtional Information
Industry             Pharmaceutical 
Location            Damandara Heights 
Working Hours  Monday - Friday 0900 – 1730
What you need to do now:
If you're interested in this role, click apply now to forward an up to date copy of your CV, or email your updated
resume to lwong@appasona.my
Thank you for your application. We regret to inform that only shortlisted candidates will be notified

Company Overview

Pasona Group, the 2nd largest employment firm over in Japan, was first established in Tokyo in 1976. It has expanded into overseas with 59 branch offices in 12 countries including Canada, America, China, Korea, Taiwan, Hong Kong, Thailand, Vietnam, Singapore, Indonesia, India & Malaysia.
Pasona HR Malaysia Sdn Bhd, was established in Malaysia in May 2014 to meet the global Human Resources needs of Japanese companies. Since its establishment, under the corporate universal philosophy of "To solve the problem of society", Pasona Group has made the variety of employment infrastructure construction. Today, as the internationalization progresses bloom, the number of Japanese companies operating in Malaysia has been increasing remarkably.
Our company moves forward to adopt all the needs of everyone in the company so that services that have been cultivated in Japan, can be also provided in Malaysia. We feel glad to provide HR consulting service to Japanese companies in Malaysia & we hope to contribute to the development of your business in Malaysia.

How To Apply

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