Role Purpose 职位目标：

To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Rx business by facilitating the submission and approval in a timely and high-quality manner in Infection Disease (ID) therapeutic area.

Key Accountabilities/Responsibilities 主要工作职责：

• Provide strategic and technical regulatory input and support to line manager to contribute for decision making on drug development strategy and license maintaining strategy to deliver the highest value to business.
• Independently compile high quality filing document complying with external and internal requirement to provide right and clear drug profile and data to NMPA to achieve targeted NDA to be approved and life-cycle management.
• Independently engage with internal and external stakeholders to follow up every milestone closely to ensure issue identified, escalated, resolved timely and target filing and approval timeline plan is achieved.
• Establish and maintain a good relationship with key regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc. via professional communication.
• Make sure line manager fully informed products registration status in daily work.
• Support line manager on budget planning and monitoring in daily work.
• Provide timely and high-quality regulatory support and input to internal key stakeholders as needed.
• Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.

Qualifications/Requirements: (Education / Experience / Competencies)

申请资格 / 职位要求：(教育背景 / 工作经验 / 知识与技能)

• A minimum of bachelor’s degree in chemistry or biological or pharmacy.
• Minimum 6 years’ experience in regulatory affairs field and at least 3 years in MNC.
• Proven ability to communicate (written/oral) with various functions and with authority.
• Fluency in English.
• Ability of cross functional co-operation.
• Strong ownership and cross boundary working mindset
• A strong capability in problem solving.
• Strong ability of lobby, influence and negotiation.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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