- 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 targetedNDA/CTA/Renewal/Variation to be approved and life-cycle management.
- Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to responsible products.
- 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 stakeholdersas needed.
- Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.
- A minimum of bachelor's degree in chemistry or biological or pharmacy.
- Minimum 4years' 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.
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CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Beijing, 中国 全职爱尔康成立于1945年,是全球眼科医疗器械领域的优秀品牌,在世界眼健康行业中一直占据优秀地位,我们的创新技术、专业口碑备受客户和合作伙伴的赞誉。爱尔康提供丰富的手术产品、隐形眼镜和隐形眼镜护理液产品、干眼药品,惠及140多个国家的数百万患者和消费者。在全球市场中,爱尔康手术产品在客户满意度、价值和创新等方面深受客户认可,隐形眼镜及护理液产品深受全球消费者的信赖。1990年,爱尔康品牌进入中国,并于1995年成立中国公司,致力于为国内眼科专家、患者和消费者提供更好的解决方案。 · 在这个岗位上,您将负责: · 维护与中央级/国家部委级政府/在华总部所在地 ...
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1215 GlaxoSmithKline (China) Investment Co Ltd Beijing, 中国 全职Role Purpose : · To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Vaccine business by facilitating the submission and approval in a timely and high-quality manner. · Key Accountabilities/Responsibilities ...
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Associate Regulatory Affairs Manager - Beijing, 中国 - 1215 GlaxoSmithKline (China) Investment Co Ltd
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描述
Role Purpose :
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 :
Qualifications/Requirements: (Education / Experience / Competencies)
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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