Overview

• Salary

  9,000 MYR ~ 10,000 MYR

• Industry

  Medical & Healthcare

• Job Description

  This role will be responsible for all regulatory affairs (RA) and pharmacogivilance (PV) matters, including but not limited to submission for and maintenance of new drug approval (NDA) of new products and existing products and Import/Wholesaler’s License. Besides, ad-hoc projects will be required to this she/he shall contribute with regulatory input.
  
  1. Product Registration
  • To ensure proper submission of NDA to the health authority (NPRA), including but not limited to, compilation of dossiers and preparation of product information (e.g., package insert and artwork of package materials)
  • To ensure accurate reporting and compliance to the regulatory requirements.
  • To be responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations and registration renewals.
  • To establish the work flow process for Regulatory Affairs
  • To coordinate with our group companies in Singapore and Japan (and third party partners as the case may be) to obtain the necessary documents and update submission / registration timeline for regulatory dossier submission.
  • To provide support or deal with the governmental regulatory authorities to secure Marketing Authorizations (MAs).
  
  2. Import/Wholesaler’s License and QA
  • To prepare and submit an application for Import License and Wholesaler License of the Company, and to be the Responsible Person named in such license.
  • To prepare, maintain and implement the necessary SOPs and other quality system that meet the requirements of the regulations with respect to product quality and GDP.
  • To discuss and agree on the allocations of roles and responsibilities between the Company and parties (e.g., distributor) to ensure appropriate product quality processes.
  
  3. Regulatory Input
  • To search, collect, analyse and evaluate the information with respect to regulatory activities, and make and send the report for them.
  • To visit regulatory authorities, important medical consultants and key customers in the public and private sectors, when necessary.
  • To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
  
  4. PV
  • To manage safety queries and other significant safety information locally, inclusive of crisis management
  • To prepare, maintain and implement the necessary SOPs that meet the requirements of the regulations with respect to drug safety.
  • To ensure the proper and timely collection, reporting and managing of safety information of the products of the Company in accordance with the regulatory requirements.
  • To ensure sufficient management of safety information to enable head office to perform a comprehensive and accurate assessment.
  • To provide non-safety staff with the regular training to ensure that they are aware of their Drug Safety responsibilities.
  • To review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
  
  5. Other
  • You may be assigned other duties from time to time.