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regulatory affairs manager.

职位概述

职位概览

    职位概述

    About the company

    Founded in the 1990s, the company is a leading pharmaceutical company in China specializing in the development, production, and commercialization of recombinant insulin analogs and injection pens. The company has become one of the main suppliers of insulin in China and now strives to broaden its global coverage in the field of diabetes diagnosis and treatment.Their US office is located in Bridgewater, New Jersey.

     

    About the team

    • Professional team members with master's and doctoral degrees and years of clinical registration experience;
    • The team culture is harmonious and the communication style is simple and direct;
    • The team leaders give space to their subordinates and encourage them to have their own opinions, and members help each other.

     

    About the position

    • You will be responsible for supporting the development and implementation of regulatory strategies;
    • You could work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents;
    • You need manage documentation systems and maintain interactions with regulatory agencies.

     

    Experience & Skills

    • Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience;
    • Deep knowledge of regulations for drugs and biologics;
    • Experience in various regulatory submissions and communication with regulatory agencies;
    • Must be proficient with both English and Chinese, develop positive relationships and collaborations.

     

    This position is based in Bridgewater, New Jersey, with the option to work from home.

    If you are interested in this company and position and have the skills, experience and work ethic required above, please click 'apply now' below to apply now. Or if you have further questions, please contact Elaine Liu at +86 10 5912 6302.

    About the company

    Founded in the 1990s, the company is a leading pharmaceutical company in China specializing in the development, production, and commercialization of recombinant insulin analogs and injection pens. The company has become one of the main suppliers of insulin in China and now strives to broaden its global coverage in the field of diabetes diagnosis and treatment.Their US office is located in Bridgewater, New Jersey.

     

    About the team

    • Professional team members with master's and doctoral degrees and years of clinical registration experience;
    • The team culture is harmonious and the communication style is simple and direct;
    • The team leaders give space to their subordinates and encourage them to have their own opinions, and members help each other.

     

    About the position

    • You will be responsible for supporting the development and implementation of regulatory strategies;
    • You could work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents;
    • You need manage documentation systems and maintain interactions with regulatory agencies.

     

    Experience & Skills

    • Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience;
    • Deep knowledge of regulations for drugs and biologics;
    • Experience in various regulatory submissions and communication with regulatory agencies;
    • Must be proficient with both English and Chinese, develop positive relationships and collaborations.

     

    This position is based in Bridgewater, New Jersey, with the option to work from home.

    If you are interested in this company and position and have the skills, experience and work ethic required above, please click 'apply now' below to apply now. Or if you have further questions, please contact Elaine Liu at +86 10 5912 6302.