Regulatory Affairs Manager

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

[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 and CAPA for identified or potential risk area according to Management Monitoring plan
7. Take initiative to support regional demand hub, local artwork coordinator and CS&L on new product/ post license variation change control and launch
8. Support the coordination for Hospital Formula Listing required regulatory document
9. Support the brand team on regulatory priority setting
10. Supervise OPAL events compliance in the team
11. Keep and Support training record completion and up-to-date
12. Conduct L2 audit per QA Annual Internal Audit Schedule
13. Support patent extension and patent linkage may need from RA

KPI
- No of product registration submitted and finished
- % of registration time control
- Regulatory compliance and conformance
- L1 audit report and CAPA
- L2 audit plan and report

[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

KPI
- Provide advise and consultation for cross-department regulatory issues in a timely manner
- Propose an adequate and effective way to implement new regulatory on time
- Work closely with TFDA through IRPMA/MRA task force
- Proactive feedback in CCR meetings and internal teleconferences
- Monitor OPAL overdue report and action taking
- Local tracker accuracy
- Management Monitoring execution
- L1 audit result and action taking for CAPA

[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

KPI
- Objective achievement
- Team members’ total performance/team spirit
- Team members’ feedback/Satisfaction
- Team members’ professional skills/knowledge level

[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

KPI
- No finding in CAG audit and TFDA recall for Artwork
- No regulation violation or non-compliant