Protégé- Regulatory Affairs

• The Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to Regulatory Authority and other administrative tasks.

• Administrative Duties:

Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photostating, store maintenance, dispatch arrangements, archiving, maintains teams repositories etc.) Submit e-payment request

• Regulatory Duties (if applicable)

Product Registration: Prepare the template of compilation of registration dossier. Assist in preparation of post approval changes (major and minor variations). Permits and tender applications Assist in handling permit applications Assist in handling name patient basis application Assist in handling import license application Provide documentation support for tender application Post Market surveillance coordination assistance System and database maintenance Assist to compile and organize regulatory final guidelines, drafts, policies, etc. Assist to support project/ process improvement.

• Self Development
  Attend relevant technical and self development trainings.

Other duties that may be assigned by GRS-IRSP Asia

Technical Skill Requirements :

Key competencies expected for the job:

• Trainings required include trainings as stated in Training Program for the Job

Training program for the job:

• Relevant and required Regulatory Systems Training

• Relevant and required SOPs as assigned in PLA and Pfizer Malaysia Policies and Procedures sharepoint.

• Relevant Malaysia & Brunei MOH Drug Registration Guidelines and regulatory processes systemOther relevant trainings

• Academic:
  
  Bachelor degree in Science
  
  Experience:
  
  
  • Affiliation and active participation in college co-curriculum activities.
  • Should be resourceful and diligent.
  • Possess good interpersonal skills.
  • Good communication skills both written and verbal.
  • Computer literate (must be knowledgeable in using MS Application: MS Word, MS Excel, MS PowerPoint), and also knowledgeable in using the internet and online sources

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Sales

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