Associate Regulatory Affairs Manager

4 weeks ago

Beijing, China GSK Full time
Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A
Posted Date: Apr 8 2024

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： 

  • 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/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 stakeholders as needed. 
  • 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 4 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 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.
    
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