Posted 2 weeks ago

Regulatory Affairs Specialist, Human Health Biosolutions

Remote Full Time

Job description

Interested in a career that matters? At Novonesis, we use biology to drive positive change for people and the planet. In our Human Health & Biosolutions (HHB) business, regulatory excellence plays a critical role in enabling innovation and securing market access for current and future products. We are now looking for a Regulatory Affairs Specialist HHB to join our APAC Regulatory Affairs team in Thailand, where you will work closely with regional and global colleagues to support business growth and regulatory compliance. The Role & Your Impact In this role, you will be a key contributor to securing and maintaining regulatory approvals for Novonesis’ Human Health Biosolutions business which includes ingredients such as Human Milk Oligosaccharides (HMOs), Probiotics, Enzymes, Advanced proteins, etc. Your key responsibilities include: Securing new and continued market access for our ingredients and maintaining existing regulatory authorizations. Develop and coordinate robust regulatory dossiers for new market access, health claims, extended usage for all ingredients as relevant. Monitoring regulatory changes and providing clear impact assessments and recommendations Regulatory advocacy - Represents within specific Industry associations, maintaining positive relationships with KOL’s and drive business positions. Engaging with Thai FDA, BIOTEC and other authorities to represent and advocate for Novonesis’ interests Participates in negotiation and interface with regulatory/enforcement authorities. Supporting local manufacturing operations and representing Regulatory Affairs during audits and inspections Contributing to APAC regulatory advocacy initiatives and cross‑regional projects Partnering closely with R&D, Quality, Operations, Commercial and Global Regulatory Affairs teams Providing early regulatory input into New Product Development and Innovation projects Ensuring all regulatory activities/registration are logged appropriately in IT systems for reporting Reviewing marketing and customer‑facing materials using a risk‑based approach Actively seek to identify and minimize risks to the business, and alerting the Head of Department Contributing to continuous improvement of APAC regulatory processes and best practices Support Sales team and customers on regulatory related queries What You’ll Need to Be Successful To thrive in this role, you bring: Bachelor’s degree or higher in Biology, Biotechnology, Food Science, Food Technology or any related fields Min. 5 years of experience in Regulatory Affairs, ideally within Food and Dietary supplements Direct experience with functional ingredients Probiotics/HMO/enzymes/proteins are an added advantage Strong negotiation and influencing skills Fluent in verbal and written Thai, English What We Offer At Novonesis, you’ll join a purpose‑driven organization where your work truly matters. We offer: A meaningful role supporting innovation and sustainable solutions Opportunities for professional development in a global regulatory community Collaboration with highly skilled colleagues across functions and regions A culture built on trust, inclusion, and continuous learning 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.

Skills and functions

  • Marketing