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    更新于 11月13日

    Regulatory Affairs Manager

    3-5.5萬
    • 北京海淀區
    • 5-10年
    • 本科
    • 全職
    • 招1人

    職位描述

    法規事務動物營養轉基因
    Are you ready for a new beginning?
    We need your talent, knowledge and dedication to better our world with biology.
    Our purpose points the way
    In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.
    We’re here to better our world with biology.
    Join us as Regulatory Affairs Manager
    In this role, you will be the China regulatory project manager responsible for the registration work of new GMM feed additives and microbes, as well as the importation license of these products. You will handle new product submissions to authorities, ensure the timely renewal of existing registrations, and create a business-aligned regional regulatory strategy for business expansion. You will collaborate with your global colleagues in Regulatory Affairs and Product Safety, as well as cross-functionally, to drive business growth in China.

    In this role you’ll make an impact by:

    · Ensure market access for animal health products in China, including feed ingredients derived from GMMs and feed microbes, by preparing submission, registration, and renewal strategies for products within the region to gain and maintain market access for Novonesis, which includes GMO certificates, new variety approval, import license etc..
    · Conduct compliance reviews and provide daily support to the business team to ensure smooth business operations.
    · Engage with external stakeholders to lobby for a more flexible regulatory system for animal products and GMM feed ingredients in China.
    · Collaborate with the global team and commercial team to plan regulatory affairs work in China, aligning with the Regulatory member of the Portfolio Management Team when relevant.
    · Support the organization in its journey of digitalization by regularly using the Veeva Regulatory data management system for dossier creation and management.
    · Coordinate with product safety as needed for animal business activities in China.

    To succeed you must hold:
    · Over 5 years experience in regulatory, R&D, or related area with extensive regulatory experience from the space of feed/animal health or BioHealth sectors. Regulatory experience of new GMM feed ingredients approval, or working understanding of biotechnology or toxicology is a plus.
    · BS degree in a relevant field, Biotechnology, Biology, Chemistry, Microbiology or other related Scientific disciplines
    · Expertise in GMM dossier preparation and panel review support.
    · Strong regulatory understanding of national animal and GMO regulations.
    · Proficiency in translating biotechnology science into regulatory language.
    · Native Chinese speaker, fluency in English, including reading, writing, and speaking.
    · Strong communication skills and the ability to connect with external stakeholders.
    · A can-do attitude and a results-oriented mindset when facing regulatory challenges.
    · Team player with excellent skills in managing global organizations and activities.
    Could our purpose be yours? Then apply today!
    At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.

    Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.
    The China Personal Information Protection Law (PIPL)
    If you apply the position on this platform, it means you agree to authorize Novonesis to use your personal information for recruitment related activities and save it in the company's global recruitment system and server overseas. We will manage, use, and protect your personal information in accordance base on personal information protection laws and regulations, as well as Novonesis global privacy policy.

    At the same time, we will also confirm with you by Email and phone. If you have any questions, please follow the “諾維信招聘” WeChat platform for more information.
    Want to learn more?
    Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com
    Not the right fit for you?
    Even if this job isn't the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away.

    工作地點

    北京海淀區諾維信

    職位發布者

    楊女士/人事經理

    立即溝通
    公司Logo諾維信(中國)投資有限公司
    諾和新元(Novonesis)是一家引領生物解決方案新時代的跨國企業。以百年創新為基石,通過運用微生物學與科技的力量,我們變革地球上的生產、消費和生活方式。在30多個行業中,我們的生物解決方案已經為眾多消費者創造價值并造福地球。我們在全球的10,000多名員工與我們的合作伙伴和客戶緊密合作,運用生物科技實現業務轉型升級。
    公司主頁
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