长沙招聘

We are looking for a Regulatory Affairs Senior Consultant to support our Regulatory Affairs Department in the registration and maintenance of pharmaceutical products (both finished products and active pharmaceutical ingredients) in China. The resource is expected to provide independent regulatory guidance to product development in strategic planning, pre-marketing, submissions and to support product launches on the Chinese market. The individual leads the submission of licenses and authorizations for the registration and maintenance of pharmaceutical products for the Chinese market. The RA Senior Consultant helps to define data and information needed for regulatory approvals in conjunction with our Regulatory Affairs Department. The role assists in the development of best practices for Regulatory Affairs processes.

    

Main responsibilities

    

Ensures compliance with regulatory agency regulations and interpretations.

    

Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

    

Involved with the preparation of necessary outlines, summaries, status reports, project reports, memos and slides.

    

Provides solutions to a variety of problems of moderate scope and complexity.

    

Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.

    

Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance with CFDA requirements

    

Provides regulatory guidance to product development teams and responds to product information requests.

    

Performs GAP analysis of API and finished product dossier for the Chinese market.

    

Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with customers’ business objectives.

    

Engages with local and/or regional regulatory agencies.

    

Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.

    

    

PROFESSIONAL EXPERIENCE REQUIRED

    

Bachelor degree from accredited college or university in science, chemistry, biology, pharmaceutical biotechnology, pharmacy, medical / scientific writing.

    

At least 4+ years of regulatory affairs or related/equivalent experience

    

Experience with domestic regulatory submissions is required.

    

Experience with or exposure to foreign regulatory submissions.

    

Experience with Japanese regulatory submissions is a plus.

    

    

Languages:

    

English: Fluent (mandatory)
Chinese: mothertongue
Japanese : nice to have

PQE公司成立于1998年，作为欧洲领头的整体质量打包解决方案服务公司，以200多名专家咨询师的优势，服务领域包括质量系统、合规注册和验证确认等领域。更致力于为客户提供数据完整性保障(Data Integrity Assuance）的整体解决方案。我们已在全球45个国家，参与或主持了8，000多个项目。我们的客户包括全球知名跨国企业和地方领头企业。我们是山德士、特瓦等公司的全球服务伙伴，同时也与赛诺菲、辉瑞、罗氏、诺华等知名制药企业保持长期稳定合作关系。

PQE目前已进入中国市场，服务中国企业。我们期望能成为一个成本最优、品质最高的服务咨询公司。将秉承We Act Locally,Think Globally的商业理念。