Regulatory Affairs Manager

Location: Petaling Jaya
Job ID: SUI11


Job description:

1.0Regulatory Affairs

  1. To ensure full regulatory compliance to all local and international regulations, codes and standards.
  2. To develop registration strategies and implement regulatory plan as scheduled or required by the business. 
  3. To co-ordinate data for new product submissions, line extensions, responses to deficiency letters and clinical trial applications.
  4. To review and approve local product information, consumer medicine information, labels as required for regulatory compliance.
  5. To maintain the registration of marketed products.
  6. To provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
  7. To monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Fresenius Kabi products.
  8. Create, develop and maintain regulatory related database and record. Organize product registration’s documents and treat legal reports (soft file & hard copy) as legal evidences in order to access and reference for the use of internal and external departments.
  9. Follow up related regulatory news in order to update and inform new information to relevant departments

2.0 Safety and Medical Information

  1. Acts as the Deputy Complaint Officer and assist the Complaint Officer in the management of product quality complaints as per required by Fresenius Kabi corporate and international standards and local Regulatory requirements.
  2. Provide regulatory support for product enquiries relating to safety and medical information, and coordinate with the global medical affairs and clinical affairs where required.

3.0 Quality Management Systems

  1. Coordinate activities related to Quality Assurance where required.
  2. Involvement in Internal and External Audits including Corporate/External Audits. Acts as an internal/external auditor as nominated.

4.0 Others

  1. To provide guidance and assistance in regulatory matters pertaining to importation requirements, logistics and customs clearance.


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