Associate Regulatory Affairs Manager

1 month ago

Beijing, China GSK Full time
勤務地: China - Beijing - ChaoYang District - Ocean International Centre - Tower A
公開日: 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. 

私たちの目標 は、世界で最も革新的で、最高のパフォーマンスを実現し、信頼される企業の 1 つになることです。私たちは、私たち全員が何かユニークなものを GSK にもたらすと信じ、知識、経験、スタイルを結集させると、その影響はとてつもないものになります。患者さんと消費者に最善を尽くす意欲を育てる GSK の冒険にご参加ください。自然体で気分よく成長し続けることができる場所です。

  

職業紹介事業所/代理店に対する重要な通知

GSK は、このサイトに掲示された空席に関して職業紹介事業所/代理店からの紹介を受け入れません。すべての職業紹介事業所/代理店は、任意の候補者を GSK に紹介する前に GSK の商業および一般調達/人事部門に連絡して事前の書面による承認を得る必要があります。職業紹介事業所/代理店と GSK の間の契約 (口頭または書面による) は、事前の書面による承認を得たことを条件として行われるものです。該当する書面による承認を得なかった場合、職業紹介事業所/代理店が実施する活動は GSK の同意による協定または契約による合意なしで行われたものと見なされます。したがって、このような活動で発生した手数料、あるいはこのサイトに掲示された空席に関して職業紹介事業所/代理店からの紹介で発生した手数料に対して、GSK は責任を負いません。

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