Hørsholm, Capital Region of Denmark, Denmark · Hybrid
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Hørsholm, Capital Region of Denmark, Denmark · Hybrid
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Hørsholm, Capital Region of Denmark, Denmark • Hybrid
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The specialist will act as the central orchestrator for regulatory master data across global functions to ensure accuracy and compliance for product registrations. They will coordinate with cross-functional teams to support market access and reduce execution risks for biosolutions.
Candidates must hold a bachelor's and master's degree in a relevant scientific discipline such as Life Sciences or Biotechnology. A minimum of 4–5 years of experience in regulatory affairs, preferably within the biotechnology industry, is required.
Want to help bring safe, compliant biosolutions to customers around the world? As Novonesis’s Global Regulatory Affairs Specialist, you will join our Global Regulatory Affairs Household Care and Industrial Biosolutions (HHC & I) team and play a central role in enabling production-linked registrations for enzyme products and ongoing compliance, with a strong focus on supporting the expansion project in India.
You will become part of a team of 11 dedicated regulatory professionals who bring diverse expertise and cultural perspectives across HHC & I industries. We work closely across functions and geographies, combining openness, collaboration, and mutual support to help advance sustainable biosolutions that are good for people, businesses, and the planet.
The role & your impact
In this role, you will act as the central orchestrator of regulatory master data across global functions, ensuring that critical data is accurate, aligned, and ready for regulatory registrations and ongoing compliance activities. This is a mixed operational and tactical role with strong strategic visibility, reporting directly to a Denmark-based manager who is closely connected to project leadership.
You will work at the center of key cross-functional interfaces, helping reduce execution risk, enable timely approvals, and support successful market access by ensuring high-quality data flow across global and local stakeholders.
Your key responsibilities in this role
Act as the single point of contact for regulatory master data across global functions, ensuring strong alignment on data definitions and timely availability of high-quality data for Regulatory Affairs activities in India.
Ensure regulatory master data is accurate, complete, consistent, and compliant across systems to support submissions and ongoing regulatory activities.
Provide regional teams with reliable, ready-to-use master data that enables efficient execution of regulatory submissions and consistent compliance across markets.
Coordinate closely with internal stakeholders across Regulatory Affairs, Product Safety, Manufacturing, Quality, R&D, Supply Chain, Project Team and Operations to ensure accurate and timely regulatory data flow.
Navigate complex regulatory environments and support cross-functional decision-making that strengthens execution and market access.
What you’ll need to be successful in this role
A bachelor’s and master’s degree in Life Sciences, Regulatory Affairs, Biotechnology, Chemistry, Microbiology, Biology, or another relevant scientific discipline.
Minimum 4–5 years of relevant experience in regulatory affairs, ideally within the biotechnology industry or related industries.
Solid experience coordinating global projects with complex frameworks and data requirements across multiple teams and stakeholders.
Strong ability to translate biotech concepts into regulatory language and practical submission requirements.
Experience working with regulatory information management systems and related digital platforms.
Excellent written and verbal communication skills in English.
Strong analytical and problem-solving skills, with a structured and detail-oriented approach.
Proven ability to manage multiple priorities, work effectively under tight deadlines, and build strong stakeholder relationships across functions and geographies.
Demonstrated ability to manage conflicts constructively and navigate complex stakeholder networks with confidence, diplomacy, and sound judgment.
Additional skills & interests we value
Project Management certification, as a plus.
Additional experience from international or highly matrixed organizations.
A strong digital mindset and confidence using digitalization tools to improve efficiency and collaboration.
A proactive, results-oriented approach combined with sound conflict-management skills.
A collaborative mindset and enjoyment of informal, multicultural working environments.
What we offer you
We offer you a meaningful opportunity to support biosolutions that make a difference for customers worldwide. You will become part of a collaborative and knowledgeable global team that values openness, continuous learning, and mutual support. In this role, you will have high visibility and a close connection to strategic priorities and project leadership. You will work in a cross-functional environment, where you can build broad stakeholder relationships and contribute to regulatory excellence across markets. Additionally, you will have the opportunity to help shape efficient and compliant regulatory processes that support innovation and sustainable business growth.
Working conditions
You will be based in Hørsholm, Denmark, working in a hybrid setup that combines time in the office with the flexibility of working from home. The role requires a minimum of three days per week on-site, with the remaining time spent working remotely.
Application deadline: 1 September 2026.
Contact Information: For questions, please contact Kelly Seligman at kelse@novonesis.com.
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.
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.
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
At Novonesis, we believe solutions rooted in biology are key to tackling the challenges our world faces. Enzymes, functional proteins and microorganisms are our planet's tiniest, yet mightiest agents of change. When we leverage their power with science, we create biosolutions that transform the way we all produce, consume and live. Today, 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 solutions enable feeding and fueling the world more sustainably, from healthy and sustainable nutrition to biofuel. Biosolutions also reduce the use of fossil-based resources, chemicals, energy and water. And this is just the beginning. The potential is almost endless. The time for biosolutions is now. And by working closely with our partners and customers, we will continue to challenge conventional thinking and transform business with biology. Together, we will create the change our world needs. Let’s better our world with biology.
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