Senior Regulatory Affairs Manager
7 months ago
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 ：
Play the critical role of 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. Provide high quality, clear and concise strategy input 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, 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 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 bachelor’s degree in chemistry or biological or pharmacy Minimum 8 years’ experience in regulatory affairs field and at least 5 years in MNC Proven ability to communicate (written/oral) with various functions and with authority Fluency in English/Mandarin Chinese 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 teamWhy 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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