Regulatory Affairs Manager

仕事内容

Product license Registration, Maintenance and Lifecycle Management

• Develop regulatory strategy/product registration plan,

• Prioritize regulatory projects and control product registration timeline
• Monitor, consult and advise regulatory processes to local staff, regional RA hub and GRA
• Address, trouble shooting for regulatory events
• Deal with Validation project based on integrated information on ongoing and forthcoming product registrations, and provide department members with consultation and support
• Conduct L1 audit and CAPA for identified or potential risk area according to Management Monitoring plan
• Take initiative to support regional demand hub, local artwork coordinator and CS&L on new product/ post license variation change control and launch
• Support the coordination for Hospital Formula Listing required regulatory document
• Support the brand team on regulatory priority setting
• Supervise OPAL events compliance in the team
• Keep and Support training record completion and up-to-date
• Conduct L2 audit per QA Annual Internal Audit Schedule
• 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

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

• Implement new TFDA regulations
• Contact window for regional/headquarters/sites/regional demand hub
• Maintain good and establish new relationship with MOHW/TFDA/CDE
• Build up communication channel for any regulatory events or issues among departments internally or between the company and the authority externally
• Compliance of Artwork registration, Artwork creation / revision initiation and final approval, and Approve the first sample of new / revised printed component
• Drive Regulation change through participation of Pharmaceutical Association Taskforce
• Complete e-learning/training on RA and QA global and local SOPs
• 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

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

• Provide/encourage training and people development to increase productivity and performance.
• Performance appraisal & objective setting Monitor on compliance
  

KPI

• Objective achievement

• Team members’ total performance/team spirit
• Team members’ feedback/Satisfaction
• Team members’ professional skills/knowledge level
  

Quality Responsibility

• Compliance of Artwork registration

• Artwork creation /revision initiation and final approval
• Approve the first sample of new /revised printed component
• Product license submission and registration approval
• Compliance of MOHW regulation
  

KPI

• No finding in CAG audit and TFDA recall for Artwork

• No regulation violation or non-compliant
  

Key Behavioral Competencies Required

• Maximizing performance with integrity

• Strategic planning and organizing skills
• Assignation of jobs and responsibilities
• Strong leadership and influencing skills
• Excellent written and verbal communication skills
  

Experience

/ Knowledge / Technical Skills Required

• Tertiary educated, pharmacy background and professional knowledge of regulatory affairs

• Business acumen
• Good communication/interpersonal skills
• Excellent English written and verbal abilities
• Oncology experience is favorable
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.
  

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.