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Lieu: Pékin, Municipalité de Pékin, Chine
ID de l'offre 12173602
Date de publication: 06/11/2019

北京/ Director-RA

JOB DESCRIPTION

Position Title                 Director-RA                                             Dept./Team    Regulatory Affairs        

职 位 名 称                                ______________________________   部 门 /组 _________________________________

Direct Supervisor    VP, Head of China Regulatory Affairs    Location                      

直 接 主 管                  ___________________________          工作地点           _________________________________

JOB PURPOSE 

  Summarizes the job’s purpose or role and why it exists in the organization

  概 述 工 作 的 目 的 或 角 色 及 其 在 机 构 内 的 价 值

This role should

  • Lead the designated product group to develop Regulatory strategy.
  • Oversee the execution process to obtain  regulatory approval to support various. development, manufacturing, sales and marketing activities for the designated product group.
  • Support RA head to develop a highly reliable and professional profile and process for AZ China and industry.

NATURE & SCOPE 

   (a)   Organization structure    组 织 机 构

           ( Please attached an updated organization chart of your team 请 附 上 你 所 属 团 队 的 最 新 结 构 图)

     -    Functionally reports to   功 能 汇 报           (Please specify position title   请 注 明 职 位 名 称)

           VP, Head of China Regulatory Affairs

     -    Operationally reports to   运 作 汇 报

           VP, Head of China Regulatory Affairs

     -    Position title of subordinates/ Number of subordinates    下 属 的 岗 位 名 称 及 人 数

           Manager / Associate Manager/ Sr. Specialist /Specialist-Regulatory Affairs

    (b)   Key working relationships    主 要 工 作 关 系

     -     Internal contacts within AZ    内 部 联 系

Medical, Clinical, Marketing, Sales, Distribution, SP & BD, R&D Project Team, Wuxi Manufacturing Site, Global Product Team (GPT), International Regulatory Affairs (IRA), Oversea Manufacturing Sites, AP Regional Office.

     -     External contacts with organizations outside AZ    外 界 联 系

National & Local Regulatory Authorities, Other Government Agencies, Artwork Agencies, Distributors, Toll Manufacturers, Hospitals and Health Professionals, Key Opinion Leaders (Medical and Regulatory), Translation/Copy Vendors, Industry Associations.

   (c)   Job requirements     工 作 要 求       

     -     Academic / Professional qualification     学 历 / 专 业 资 格

  • Bachelor or above in Pharmacy, Medical, Biology or related field

     -     Technical / skills training    技 术 / 技 能 训 练

  • Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
  • Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
  • Strong ability on team management and building solid trust partnerships among peers and junior staff.
  • Excellent verbal and written communication skills and reasonable good enough English, capable in English reading/writing/listening/speaking.
  • Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.
  • Good project management skill and experience.

  • Working experience

( no. of years  年 资   job function  工 作 功 能   business types  业 务 种 类 )

Essential     必 需      

  • > 3 years experience in below positions.
  • Experience in handling complex regulatory projects, various kinds of regulatory submissions/approvals and experiences in involving into the development projects are required;
  • Experience in complex regulatory environment assessment;
  • Experience in crisis management
  • At least 3 years people management experience with demonstrated leadership and management skill in leading a team.

              Desirable    理 想

  • Management experience in MNC

     -     Language ability    语 言 能 力

  • Chinese and English (proficiency level)   

     -     Computer literacy    电 脑 知 识

  • Word, Excel, Power point

     -     Others    其 他        

  • China Pharmacist/Physician License is plus.

  DUTIES & RESPONSIBILITES 

Key Result Areas

(in order of importance)

% of Time

Key Tasks

Performance Indicators

Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs

10%

  • Align with the values and vision of AZ
  • Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, AZ code of conduct
  • Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
  • Disclose potential breach of codes or conduct
  • Follow SOP requirements especially on documentation
  • Self display behaviours consistent with the AZ vision and values
  • No non-compliance issues raised with local and global policies and procedures
  • No valid complaint, recall, etc. from internal & external customers on “local regulatory approved” components
  • No breach of confidentiality
  • No major findings in SOP implementation audit

Maintain product licenses in assigned portfolio through timely renewal to a high standard

5%

  • Monitor status of product licenses
  • Project manage changes in product licenses and coordinate with other changes, planned and in progress
  • Maintain complete documentation records
  • Communicate changes to license status promptly

  • No unintentional loss of product license
  • Accurate & complete records in place, including, where appropriate, good audit outcomes

For allocated portfolio develop and action regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch

30%

  • Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy
  • Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities
  • Develop regulatory plan in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time
  • Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
  • Clearly documented and communicated strategy agreed with all key stakeholders
  • New products are registered and launched on or ahead of plan with the best label as agreed in the strategy
  • No objection raised by GPT, IRA or MCP in terms of developed regulatory strategies
  • Prompt and continual report on status to key stakeholders

Build and retain effective regulatory team, maintain cross-functional communication

15%

  • Recruit, retain and motivate a regulatory team
  • Agree team members’ roles, responsibilities, performance criteria, objectives and standards of work execution.
  • Communicate as required and ensure effective downwards and upwards communication channels are in place
  • Direct, coach, guide, support, reward and develop the team.
  • Identify development plan for each regulatory member and manage poor performance
  • Facilitate and solve conflicts, within the team and cross-functionally.
  • Encourages the sharing of best practices
  • Interaction in team is positive and works as part of the team, behaviours are consistent with AZ performance culture – as measured by feedback from team members
  • High level of observable cross-functional interaction – feedback from other functions
  • Agreed performance objectives with subordinates in place (annually)
  • Existence of career / succession plans
  • Competence gap analysis in place
  • Personal Development Plan for team  in place and updated as appropriate
  • Agreed performance objectives with subordinates in place (annually)

Provide Leadership and direction to team

10%

  • Create and communicate a clear vision for the team
  • Strive to ensure high levels of performance and achievements.
  • Take decision and accountability for actions.
  • Build commitment within the team.
  • Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
  • Challenge status quo for continuous improvement.
  • Help build an open and trusting atmosphere.
  • Observable positive behaviours are in line with company values, feedbacks from Directors & Managers
  • Positive feedback from other team members

Actively develop excellent relationship with local regulatory authorities and external stakeholders

10%

  • Build up AZs good image through high professional standard of application, response to enquiries etc.
  • Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
  • Number of contacts made with regulatory authorities
  • Regulatory authorities feedback

Drive issue Management

10%

  • Provide detailed analysis on regulatory status of affected products
  • Develop and undertake assigned follow-up action where necessary
  • Negative impact on relevant products is minimised
  • Documentation of fast and effective communication internally and externally so as to achieve objectives and resolution at high ethical standards
  • Positive feedbacks from MCP and Directors
  • Key local messages are in-line with those agreed globally 

Maintain the awareness of, and shape the regulatory environment relevant to the assigned portfolio

10%

  • Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products
  • Communicate the impact of changes to key stakeholders.
  • Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes

  • Key stakeholders in International Regulatory Affairs and MC satisfied with speed and appropriateness of communications.
  • Trend towards faster approval
  • Gradual reduction in regulatory hurdle

Preparation and Approval of Job Description

Version

Description of Change

Prepared by

(signature and date)

Approved by

(signature and date)

Effective date

1.0

1. New JD template.

Job Holder Acknowledgment of Job Description Requirements

Signature

Date

福利Benefits:

  • 定期体检
  • 医疗保险及子女医疗保险
  • 企业年金
  • 通讯补贴
  • 补充商业保险

投递方式 Application Channel:lan.zheng@astrazeneca.com

生效日期Date Posted:2017.7

截止日期Closing Date:2017.9

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Director-RA-BJ
Réglementation

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