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Regulatory Affairs Manager, Pharmaceutical Products and Services China

Date: Jun 12, 2021

Location: Shanghai Xinzhuang, CN

Company: Evonik Industries AG

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See what chemistry can do for your career: careers.evonik.com


Exploring opportunities. Growing together.

 

VACANCY REFERENCE NUMBER 144455
 

Regulatory Affairs Manager, Pharmaceutical Products and Services China

 

Location: China : Shanghai Xinzhuang

Function: Innovation Management (R&D)

Career Level: Senior professionals (> 5 years)

Legal Entity: Evonik Specialty Chemicals (Shanghai) Co., Ltd

Business Line: Health Care

 

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

 

RESPONSIBILITIES

  • In charge of the application and maintenance of drug import licenses for drug substances and their intermediates.
  • Coordination of and guidance to the dossier preparation for China in the international regulatory affairs API-group.
  • Surveillance of new policies for C-DMF to APIs and import licenses in China.
  • Writing and updating of guidance SOPs for registrations of APIs in China. Training of the international regulatory group to registration process in China for existing and new guidelines.
  • Communication with Chinese authorities to follow up on the licenses and C-DMF registration process.
  • Communication with customers in China for business support on regulatory affairs.
  • Communication with associations that may impact Chinese pharmaceutical regulations.
 

REQUIREMENTS

  • Bachelor or above with technical, natural science or pharmaceutical background
  • At least 10 years working on pharmaceutical and API regulatory affairs
  • Industry group engagement
  • Good knowledge of the quickly adapting Chinese pharmaceutical regulations
  • Some oversight on pharmaceutical regulations in US, EU, Japan and other Asian countries.
  • Presentation and communication skills
  • Solution driven
  • Fluency in English and Mandarin
  • Fluency with MS Office, SAP, and other office applications
 

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 144455

#LI-TG1

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.