Senior Regulatory Affairs Specialist

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Position title:

Senior Regulatory Affairs Specialist – Human Health Biosolutions (EMEIA)

Location:

Hybrid role based in Türkiye (primary). Support to other EMEIA markets as required.

Team description

You will join the Human Health Biosolutions (HHB) Regulatory Affairs EMEIA team, part of Novonesis’ global Regulatory Affairs organization.

The team supports market access and lifecycle management of HHB products by ensuring compliance with regulatory frameworks across Europe, the Middle East, Africa, and other selected markets. We work closely with global Regulatory Affairs colleagues and cross‑functional partners to translate scientific innovation into compliant, market‑ready solutions.

Our work directly supports Novonesis’ purpose, “Better our world with biology,” by enabling safe and timely access to probiotics, prebiotics, HMOs, enzymes, novel vitamins, and other biosolutions.

The team operates in a collaborative and trust‑based environment where regulatory professionals are valued as subject‑matter experts and strategic partners, combining strong regulatory expertise with sound business understanding.

As Senior Regulatory Affairs Specialist – Human Health Biosolutions (EMEIA), you will play a strategic and hands‑on role in supporting and enabling market access for HHB products, particularly across Türkiye and the Middle East, with additional support to Europe and Africa. You will operate at the intersection of science, regulation, and business, influencing regulatory strategies, supporting customers, and partnering closely with internal stakeholders.

This role is ideal for a regulatory professional ready to take on a highly visible role with real business impact, offering exposure to cutting‑edge biosolutions, emerging regulatory topics, and development opportunities within a global organization.

Main tasks and responsibilities

This role has a mixed operational and tactical scope with senior‑level strategic contribution, operating as a senior regulatory expert within the EMEIA region. The position has regional scope, with responsibility for assigned markets, product categories, and regulatory topics.

Key responsibilities include:

Provide regulatory expertise to support compliance and market access

Provide expert regulatory guidance to support compliance of HHB products with applicable food, dietary supplement, and selected drug‑related regulations, particularly across Türkiye and the Middle East, with additional support to Europe and Africa.

Act as a regulatory subject‑matter expert and point of contact for assigned markets and product areas.

Regulatory submissions and lifecycle support

Independently prepare, review, and coordinate regulatory dossiers to support market access and lifecycle activities.

Support post‑approval changes, renewals, and maintenance activities.

Coordinate follow‑ups and responses to Health Authorities in alignment with regional and global Regulatory Affairs strategies.

Regulatory intelligence and strategic contribution

Monitor and interpret evolving regulatory requirements across EMEIA.

Translate regulatory developments into clear, actionable guidance for internal stakeholders.

Contribute expert input to regulatory strategy discussions, advocacy initiatives, and harmonization activities.

Business and customer support

Act as a trusted regulatory advisor to Sales, Product Portfolio, PMT, and customers.

Support customer regulatory requests and enable compliant commercial opportunities.

Digital tools and documentation

Maintain accurate regulatory documentation and data within Veeva.

Contribute to continuous improvement and adoption of digital regulatory tools and ways of working.

Complexity of the role

This role operates in a complex and dynamic regulatory environment, requiring strong judgment, prioritization, and subject‑matter expertise.

The focus is on expert execution, optimization, and contribution to innovation. The role exercises influence through regulatory expertise and stakeholder collaboration rather than formal decision authority.

You will work closely with:

Global and regional Regulatory Affairs colleagues

Commercial, portfolio, and project teams

External stakeholders such as Health Authorities, consultants, and trade associations

The role requires navigating regulatory uncertainty and diverse regional requirements while maintaining strong alignment with global regulatory frameworks and business priorities.

Experience and education

Required

Bachelor’s degree in Food Science, Pharmacy, Biotechnology, Life Sciences, or a related field.

Typically 7+ years of experience in Regulatory Affairs within dietary supplements, probiotics, or food, BioSolutions, or life sciences industries.

Hands‑on experience with regulatory submissions and approvals.

Solid knowledge of Türkiye and Middle East food and dietary supplement legislation.

Solid understanding of the EU regulatory framework, including Novel Foods.

Fluency in written and spoken English.

Nice to have

Experience with African regulatory frameworks.

Experience working in a global or matrix organization.

Exposure to novel ingredients or emerging technologies (e.g., HMOs, precision fermentation).

Competencies and personal qualities

To succeed in this role, you bring strong analytical and regulatory interpretation skills and the ability to translate complex regulations into practical, business‑relevant guidance.

You demonstrate effective stakeholder collaboration and influencing skills, high attention to detail with a pragmatic, solution‑oriented mindset, adaptability and resilience in fast‑changing regulatory environments, and clear, confident communication skills, both written and verbal.

You thrive as a senior expert in a collaborative environment and are motivated by enabling innovation while safeguarding compliance and consumer safety.

Ways of working

Hybrid working model with a high degree of flexibility and autonomy.

Limited travel is expected, including domestic travel for meetings with authorities, customers, or consultants, and approximately 1–3 international trips per year, primarily to Denmark.

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