Role Purpose：

To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China CEP business by facilitating the submission and approval in a timely and high-quality manner.

Key Accountabilities/Responsibilities：

• Play a critical role in providing 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 in charge of all CMC regulatory relevant activities for CEP products, including CMC strategy making and implementation, CMC document preparation, CMC technical communication, CMC issues solving, QC testing, ChP, bundling review, etc.
• Provide high quality, clear and concise strategy, and advice on general regulatory topics.
• 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 labeling and drug features to be approved.
• 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, 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 such as medical and commercial as needed.
• Significantly contribute or lead function continuous improvement initiative
• Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.

Qualifications/Requirements: (Education / Experience / Competencies)

• A minimum of master’s degree in pharmacy, chemistry or biological or related background.
• Strong scientific expertise relevant to CMC, Understanding of chemical and pharmaceutical subjects as well as of GMP requirements.
• Substantial understanding of and experience in chemical and pharmaceutical drug development, chemical and pharmaceutical production, quality control and quality assurance.
• Minimum 8 years’ work experience in regulatory affairs field and at least 5 years in regulatory CMC field.
• 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.
• Ability to coordinate, influence and lead people or a virtual team.

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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