上海招聘

Job Summary

The Regulatory Affairs Specialist provides support in regulatory affairs -global and local, and ensure all regulatory services are provided upon customers’ requests and assisting Regulatory Affairs Supervisor (RA Supervisor) with maintaining the Regulatory requirements at all levels in the company. Key responsibilities include: preparing and maintaining regulatory documents, providing appropriate solutions upon requests from internal and external customers, reporting revision and update of pharmacopoeia standards, providing accurate and effectively response to drug evaluation and supervision institutions of each level, understanding excipient-relevant regulations and monitoring any update in regulations.   

**Internal Customers include local and regional commercial team, global regulatory, technical and quality team. External customers include local regulatory authorities and Colorcon customers.**

Main Responsibilities 

• The most important performance objective for this position is, according to the business priority, to compile and submit regulatory application documents based on Excipient or other related regulations and follow up on the progress accordingly. The interim steps necessary to achieve this objective are:

  • Keep up-to-date knowledge about all the related regulations and understand where and how to get the latest information.

  • Clearly understand product’s features, related technologies, quality control aspects etc.

  • Keep effective communication with regional and global teams in the company to clarify and collect needed information.

  • Be able to identify potential risks and obstacles during the application process and timely report to RA Supervisor and suggest solutions to move things forward.

• The other important task is to handle customer regulatory questions and queries in related with company products for drug and dietary supplement application globally and locally via Customer Support Solution System and other channels.

• Monitor and update RA Supervisor with repeated customer queries or new changes in regulations for developing standard responses.

• Cooperate with Global RA Team to handle regulatory question within and cross regions.

• Maintain current and working knowledge of regulatory information and changes related to excipients and drugs/food that have direct or indirect effect on the business.

• Support global RA on regulatory related projects or tasks.  Participate global regulatory review meetings.

• Provide support for industry association affairs.

• Perform additional general duties arranged by RA Supervisor.

                    

Key Performance Objectives

In the first 3 months

• Learn about company business/products/key processes.

• Learn how to use Customer Support Solution System.

• File all the regulatory related documents in order as a learning task to understand all the related working knowledge.

In the first 6 months

• Be familiar about current joint review regulations and be able to prepare registration dossier independently.

• Be able to handle customers’ requests in different types through Customer Support Solution System.

• Be able to provide appropriate regulatory response to internal and external requests with the help of RA Supervisor. 

In the first 12 months:

• Achieve set performance targets for the role.

Requirements

• Bachelor or above degree in pharmaceutical, chemical or related disciplines. Having the success experience of submitting excipients filing dossiers to CDE is preferred.

• 1 to 2 years’experience in RA management or technical service, quality function in pharmaceutical related industry.

• Positive and Energetic, Easy to communicate, Conscientious & Responsible.

• Good interpersonal communication skills, strong self-motivator, ability to build effective working relationships & handle the work independently.

• Proficient with regulatory data applications, regulatory websites, and general computer skills.

• Fluent English speaking and writing.

卡乐康(Colorcon)是全球药剂开发领域的领导者，总部位于美国费城，成立于1961年，至今已有50年以上的历史。卡乐康以优质的产品、领先的制药技术及全面的增值服务，成为全球制药企业配方的合作伙伴。
卡乐康自1993年近入中国市场，并于1996年正式注册上海卡乐康包衣技术有限公司。在进入中国20年间，卡乐康推动了薄膜包衣及配方技术在中国制药领域的快速发展。我们的专利产品欧巴代(Opadry)系列，已经成为该领域中运用最广泛的产品之一，代表了当今薄膜包衣技术的最高水平，从而也为中国市场提供了与世界同步的选择。
经过多年的磨练，我们在中国的生产规模、员工队伍、销售利润都有了快速地增长，同时确立了在行业中的领导地位。欢迎你查看我们的网站——www.colorcon.com， www.colorcon.com.cn 来获得对公司情况的进一步了解。你会对我们是药用辅料领域的全球领先者以及我们将面临的巨大发展机会而感到兴奋!
因公司业务发展需要诚聘英才，如感兴趣者请联系我们
邮件:rying@colorcon.com