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Posted 2 weeks ago
Regulatory Affairs Manager APAC
Job description
Interested in a career that matters? Join us as our new Regulatory Affairs Manager! Are you passionate about Regulatory Affairs, and interested in working for one of the world’s most sustainable Biosolutions companies? We are looking for a Regulatory Affairs Manager to join our APAC Regulatory Affairs team responsible for Human Health Biosolutions (HHB). In our department, we are responsible for securing both current and future business for Novonesis by ensuring that all ingredients and product offerings—spanning Probiotics, Postbiotics, Human Milk Oligosaccharides, and Precision Proteins—remain compliant and have seamless market access. This APAC role focuses on executing regional regulatory strategies aligned with global priorities, enabling one strong, unified voice across Novonesis RA, while fostering close collaboration with local health authorities. You will join a passionate group of colleagues who love what they do and are always ready to share their knowledge and experience. We are part of the Regulatory Affairs and Product Safety (RAPS) organization. In This Role You’ll Make An Impact By Lead and coordinate APAC team, exercising influence‑based leadership to drive collaboration and deliver on RA priorities. Lead regulatory submissions, registrations, and market access processes for GMM‑derived Precision Proteins, ensuring compliance for current and new innovations. Lead and coordinate APAC regulatory activities across countries, influencing peers and global stakeholders to ensure alignment and delivery. Lead regional advocacy and external engagement, collaborating with regulatory authorities, trade associations, and industry groups while monitoring regulatory trends and communicating business impacts. Driving execution of regional regulatory strategies in line with global priorities, translating strategy into clear, actionable regional plans. Support New Product Development (NPD) by delivering regulatory input and driving regional RA projects in close alignment with global RA teams and policy initiatives. Proactively identify, assess, and mitigate regulatory and business risks through Enterprise Risk Management. Embed digitalization to enhance APAC RA workflows, enabling efficiency, data‑driven insights, and harmonization of RA best practices and systems. To succeed you must hold: Bachelor’s degree or higher in Biology, Biotechnology, Food science, Toxicology, Chemistry, Biochemistry, Genetic engineering or related field. Min. 10 years’ work experience in Regulatory Affairs, ideally with exposure to FMCG / Consumer Health/ Ingredients B2B. Direct experience and knowledge in Genetically Modified Microorganisms (GMM) are an added advantage Proven track record of effective engagement with internal and external stakeholders. Fast learner with strong sense of ownership, able to work independently and collaboratively in a matrix organization Strong proficiency in English (oral & written). Excellent negotiation, communication and influencing skills. Our purpose guides 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. If our purpose resonates with you, we encourage you to apply. Opportunities for everyone We are committed to an inclusive recruitment process and equal opportunity for all applicants. Therefore we ask you to apply without a cover letter or photo and instead include a few sentences in your CV explaining your motivation for applying. We make all employment decisions based on business needs and welcome candidates with a wide range of backgrounds, including ethnicity, religion, gender, sexual orientation, age, disability, or veteran status. Explore other openings If this position isn’t the right fit, you may still find other opportunities with us. You’re welcome to explore open roles or create a job agent to stay connected with future opportunities at novonesis.com/Career Before you submit your application, you can update your Language Settings in the top bar. Here, you can choose from a selected set of languages to ensure that communication is sent in your preferred language. Create a job alert, and we’ll let you know when new opportunities matching your interests open up. To create a job alert: Click this link to set up a job alert. Please note: You’ll need to sign in or create an account to proceed. Once signed in, select “Create Job Alert”. Choose the job categories and locations that match your interests. Click “Create” - and we’ll notify you directly when a relevant position is posted. Choose a career that matters - and never miss an opportunity to make a difference. In 2024, Chr. Hansen and Novozymes joined forces to form Novonesis. We are 10,000 people worldwide whose expertise spans more than 30 different industries. All around the world our biosolutions already create value for thousands of customers and benefit the planet. Our biosolutions enable feeding and fueling the world more sustainably, from healthy and sustainable nutrition to biofuel. Our biosolutions also reduce the use of fossil-based resources, chemicals, energy and water. And this is just the beginning.