Regulatory Affairs Manager

Novonesis

  • 北京市海淀区
  • 长期
  • 全职
  • 2个月前
Are you ready for a new beginning?We need your talent, knowledge and dedication to better our world with biology.Our purpose points the wayIn 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 ManagerIn 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)
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