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Regulatory Affairs Group

(Senior) Manager, Regulatory Affairs - Established Products

  • Titre (Senior) Manager, Regulatory Affairs - Established Products
  • Fonction Regulatory Affairs Group
  • Sous-fonction Regulatory Affairs
  • Lieu Xi'an, Shaanxi, China; Beijing, China
  • Date de mise en ligne
  • Référence 2406161425W
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Description

Summary of Job Responsibilities:
1.    Develop regulatory strategy plans to lead successful life cycle management (LCM) of marketed products including line extensions and variations and provide Regulatory expertise to local products and cross-functional teams.
2.    Ensure timely Regulatory filings and response to HA queries for marketed products.
3.    Lead for in country QC testing to support the Filings.
4.    Provide mentoring and coaching to junior staff members.
5.    Establish strong relationship with HA and key stakeholders in the local, regional and global organization.
6.    Perform with high quality and compliance. 

Dimensions of Job:
1.    Regulatory LCM strategy support for marketed products 
2.    Regulatory strategy input to BU and product teams
3.    Liaise with Regulatory agency
4.    Regulatory process development & resource planning

Principal Accountabilities of Job:
1.    Collaborate with global, regional and local product teams to develop and implement registration plan and strategy.
2.    Oversees regulatory activities & review critical submissions for assigned projects.
3.    Ensure timely Regulatory submission and team response efforts to HA query.
4.    Lead cross-functional preparation for CDE consultation meetings.
5.    Interact with HA review divisions.
6.    Actively lead or involve in review and revision of regulations, guidelines.
7.    Develop internal regulatory process for effective operation.
8.    Credo based behavior with regulatory compliance excellence.

Key Performance Measures: 
1.    Regulatory strategy and timeline consistency 
2.    Timely delivery with high quality
3.    Good HA connection and leadership
4.    Others:  Crisis management, people development, as active contributor in some policy work

Qualifications

1.    Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
2.    Minimum of 5-8 years regulatory affair related experience in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.
3.    Strong oral & written communication skill; Strong leadership capability and ability to work under pressure. 
4.    In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
5.    Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
6.    Proficiency in verbal and written English; good computer skill, good presentation skill.

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