求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Regulatory Affairs Manager

  • 全職

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

工作條件

  • 接受身份: 上班族
  • 工作經歷: 十年以上
  • 學歷要求: 大學 碩士
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Key Behavioral Competencies Required:
    1. Maximizing performance with integrity
    2. Strategic planning and organizing skills
    3. Assignation of jobs and responsibilities
    4. Strong leadership and influencing skills
    5. Excellent written and verbal communication skills

    Experience / Knowledge / Technical Skills Required:
    1. Tertiary educated, pharmacy background and professional knowledge of regulatory affairs
    2. Business acumen
    3. Good communication/interpersonal skills
    4. Excellent English written and verbal abilities
    5. Oncology experience is favorable

福利制度

[正職人員]
1. 週休二日
2. 年休假10天以上
3. 享勞保.健保及團保(配偶及子女)
4. 員工健康檢查
5. 年度旅遊
6. 三節禮金,結婚及生育禮金
7. 績效獎金
8. 完整的教育訓練計劃
9. 業務行銷同仁購車無息貸款

[約聘人員]
比照勞基法

更新日期:2021-03-04

應徵方式

  • 職務聯絡人: HR
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內11-30人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年7%
5~10年0%
10年以上93%
學歷分佈
碩士及以上71%
大學29%
專科0%
高中0%
高中以下0%
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