Director of Regulatory Affairs Policy and Intelligence

    • Beijing, China

Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A
Posted Date: Feb 21 2020
Key Accountability/Responsibilities

  • Define priority regulatory policy topics, provide strategic direction and insight to staff in regulatory, medical, marketing, product supply and, where relevant, ensure to policies are communicated in an appropriate channel.
  • Define and execute external policy strategies to deliver planned outcomes including interactions with key decision makers at regulatory agencies and governments and at the trade association level.
  • Monitor China legislation/regulations/guidelines, provide interpretation, advice and perspective on possible impact for GSK and archiving in a timely manner
  • Ensure close collaboration with internal partners including government affairs, value/access, operations, R&D functions and commercial.
  • Drive external network and relationship building to ensure policy objectives can be pursued, including representation at trade associations like RDPAC, EFPIA China Network etc., and direct engagement with key decision makers.

Internal:
  • To be the primary contact for China on regulatory policy and intelligence requests and question.
  • Effectively represent RA in regulatory intelligence data gathering, review, report writing and recommendations.
  • Responsible for monthly MT team Policy interpretation, RA inside policy interpretation & training.
  • Depends on business needs, make the communications and be an internal advocate on behalf of China RA with R&D function, marketing, legal, Clinical Operation, Product Supply, etc.
  • As Global RPI China's representative, Global intelligence relevant team member, China country report /RA representative, to deliver out one voice by leading RA RI team.
External:
  • Advocate the company's regulatory, scientific and medical positions on new and existing initiatives to key external decision makers.
  • Showing leadership in different TF with well-known soft skill.
  • Enhance company's visibility through proactively engagement including at Trade Association, such as RDPAC, PhRMA.

Qualifications/Requirements: (Education / Experience / Competencies)
  • A minimum of bachelor's degree in life science (pharmacy, chemistry, biology or related background) plus 10 years regulatory affairs working experience and over 5 years leadership role experience in MNC Company.
  • Experience in complex regulatory environment assessment Makes valuable contributions to the development of regulatory practices, procedures and standards.
  • Highly skilled at analyzing and interpreting complex information with ability to assimilate and summarize in a clear and concise manner.
  • Proven ability to communicate (written/oral) in English
  • Ability to build and maintain strong personal networks both internal and external to GSK.
  • Good verbal and written communication skills
  • Ability to present clearly and effectively to a variety of audiences inside and outside Good leadership and people-management skills including leading an efficient and well-motivated team
  • Ability to handle with emergency things and provide quick response


*LI-GSK

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