Career Category

Job Description

Job Purpose

• Lead the team to create and implement China regulatory strategy cross TA to ensure innovative and high-quality execution to the Health Authority in China, to support the business continuities and growth.  
• As a senior leader of the China RA team assist the China RA head to optimize local/global strategy management process to meet Chinese regulation requirements and Amgen global process and standards.

  Job Summary:

• Lead the cross TA strategy members to establish RA regulatory strategy and model in China. Analysis the gaps and needs for China RA, together with global and local team to build up China regulatory strategy team’s capabilities to be fully integrated into global process. Continuously optimize local strategy management process to meet Chinese regulation requirements and global Amgen standard.
• Lead RA TA strategy team to provide expertise to China and global project teams to ensure the innovative, timely, quality execution of paper and electronic submission to Health Authority starting from early phase projects and simultaneous global submission.
• As main contact for HA advocacy and cross project meetings Being strategic partner with Operations, Policy and CMC senior leaders within China RA，global regulatory system and China Clinical, Medical and Market access functional partners , proactively manage and drive changes and implementation of enhanced regulatory innovation approaches and ensure China RA being compliant with regulations, Amgens’ global and local policy, procedures, SOPs

• Strong in connection network within NMPA, CDE, CDME, China Pharmacopeia, and all relevant agencies within NMPA system
• Ability and desire to lead an Industry partners to propose policy or procedure recommendation to HA
• Represent Amgen Regulatory or Amgen China Regulatory in the public situation to deliver Amgen messages when it is needed
• Aim to build the team capabilities and to lead a China/global team on initiatives/process to facilitate for simultaneous global development and submission

• Being strategic partner with China cross and global cross functions
  • On driving and working with RA associates to identify process improvement areas
  • Develop and sponsor on update of local strategy working process
  • Oversee implementation of all project deliverables by strategists
  • Be responsible for hiring, retaining, developing, and proposing training, capabilities building and career development for members in strategist team
  • Collaborate with global, on China RA-related strategy building process and initiatives

• Support RA Head to lead the China RA team when situation needed and prepare to be a natural successor

Knowledge and Skills

• Regulatory expertise in new drug development preferred in biotechnology products, medical devices
• Extensive experiences on interactions with regulatory authorities
• Working experiences with policy advocacy, procedures and SOPs
• Knowledge of national legislation and regulations relating to medicinal products and is able to engage equal dialog with HA
• Understanding of the registration procedures in China, in US, in Europe (Centralized, Mutual Recognition and Decentralized), in Japan for MAA, variations, extensions and renewals
• Understanding of new drug development and LCM
• Experience managing regulatory processes and lead regulatory team
• Scientific / Technical Excellence
• Leadership Skills
• Communication Skills: Oral and Written in Chinese and English
• Negotiation Skills
• Ability to anticipate and prevent potential issues

Basic Qualifications:

Bachelor degree or above in life sciences, Pharmacy or Chemical equivalent experience

Language:

Fluency in English and Chinese (oral and written)

Experiences:

Have experiences of leading a team Have experiences of management multiple projects independently Have more than 12 years working experiences in multinational companies and in regulatory Experiences of working and communication with cross-functions in local and global Have good skills or understanding to use IT tools

Competency Profile:

Leading a diversity team, can drive good result with tracked record Customer and quality focused Good communication and influencing competence during global, region project or interactions Having strategic thinking and learning agility 

Specific professional competencies:

Pharmaceuticals or medical education background is preferred