Assistant Regulatory Affairs Manager

Basic qualifications:

● At least 5 years Regulatory Affairs experience is a MUST

● Pharma background

● Maximizing performance with integrity

● Strategic planning and organizing skills

● Assignation of jobs and responsibilities

Preferred qualifications:

● Strong leadership and influencing skills

●. Excellent written and verbal communication skills

●. Tertiary educated, pharmacy background and professional knowledge of regulatory affairs

●. Business acumen

●. Good communication/interpersonal skills

●. Excellent English written and verbal abilities

Details:

【Primary Objective of Position】

Manage regulatory activities in facilitating GSK business goal achievement and ensure commercial activities to comply with government regulations and corporate regulatory policies

【Key Accountabilities / Responsibilities】:

● Product license Registration, Maintenance and Lifecycle Management

  1. Develop regulatory strategy/product registration plan,

  2. Prioritize regulatory projects and control product registration timeline

  3. Monitor, consult and advise regulatory processes to local staff, regional RA hub and GRA

  4. Address trouble shooting for regulatory events

  5. Deal with Validation project based on integrated information on ongoing and forthcoming product registrations, and provide department members with consultation and support

  6. Conduct L1 audit for identified or potential risk area

  7. Take initiative to support regional demand hub, local MLCC and CS&L on new product/ post license variation change control and launch

KPI

  • No of product registration submitted and finished
  • % of registration time control
  • Regulatory compliance and conformance
  • L1 audit report and CAPA

● Drive Regulatory Change and Process

  1. Gain regulatory intelligence to cope with regulatory environment change and seek for business opportunities and report new regulations on biological products to GRA

  2. Implement new TFDA regulations

  3. Contact window for regional/headquarters/sites/regional demand hub

  4. Maintain good and establish new relationship with MOHW/TFDA/CDE

  5. Build up communication channel for any regulatory events or issues among departments internally or between the company and the authority externally

  6. Compliance of Artwork registration, Artwork creation / revision initiation and final approval, and Approve the first sample of new / revised printed component

  7. Drive Regulation change through participation of Pharmaceutical Association Taskforce

  8. Complete e-learning/training on RA and QA global and local SOPs

  9. Ensure team compliance on quality and regulatory requirement internally and externally e.g. OPAL reporting, GMS

● People Development and Management

  1. Manage and coach RAA/RAS to equip them with advanced regulatory knowledge and professional skills

  2. Provide/encourage training and people development to increase productivity and performance.

  3. Performance appraisal & objective setting

  4. Monitor on compliance

● Quality Responsibility

  1. Compliance of Artwork registration

  2. Artwork creation /revision initiation and final approval

  3. Approve the first sample of new /revised printed component

  4. Product license submission and registration approval

  5. Compliance of MOHW regulation
  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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