Regulatory Affairs Officer International

Regulatory Affairs Officer International

At  Prothya Biosolutions , we are dedicated to developing and supplying life‑saving plasma‑derived medicines that improve the lives of millions of patients around the world. Our colleagues are passionate, committed, and always willing to go the extra mile to make a difference.

As our organization continues to grow internationally, we are looking for a  Regulatory Affairs Officer International  to join our Regulatory Affairs team. This is an exciting opportunity to contribute to our global expansion by supporting product registrations in international markets outside the EU, UK, and US. You'll become part of a dynamic and collaborative team with diverse expertise, where innovation, continuous learning, and professional development are encouraged.

Your Role
As a Regulatory Affairs Officer International, you will coordinate and support regulatory activities for international markets through Prothya's business partners and their affiliates. You will work closely with both internal departments and external stakeholders to ensure timely and compliant product registrations.

Your responsibilities include:

Coordinating and managing international registration submissions for medicinal products and intermediates through business partners and their affiliates.

Monitoring submission timelines and ensuring registrations are completed efficiently.

Acting as the primary liaison between business partners, affiliates, and internal departments to obtain the required regulatory documentation.

Collaborating with Regulatory Affairs, Commercial, Quality, Manufacturing, Medical Affairs, and other departments to prepare high‑quality submission packages.

Coordinating responses to questions from international regulatory authorities and collecting the necessary supporting information.

Preparing regulatory statements, justifications, and correspondence for international health authorities when required.

Maintaining accurate regulatory documentation, submission records, and registration status overviews.

Providing regulatory advice and support to internal stakeholders and international business partners.

Writing, reviewing, and updating Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to international regulatory activities.

Supporting continuous improvement of regulatory processes.

Your Profile
You are an organized and proactive regulatory professional who enjoys working in an international environment. You communicate effectively with stakeholders across different cultures and are comfortable coordinating multiple projects simultaneously.

What you’ll bring

Bachelor's degree in Pharmacy, Biology, Biochemistry, or a related Life Sciences discipline.

2-5 years  of experience with international regulatory registrations of biological products.

Experience with International registrations is highly preferred.

Knowledge of export dossiers and European regulatory procedures.

Experience working in cross‑functional project teams.

Excellent written and spoken English.

Ability to work independently while collaborating effectively within larger teams.

Detail‑oriented and well‑organized.

Strong communication and coordination skills.

Assertive and confident in stakeholder management.

Positive, flexible, and solution‑oriented.

Proactive with a continuous improvement mindset.

Able to perform well under pressure and manage multiple priorities.

What We Offer
At Prothya Biosolutions, you'll work in an inspiring environment where your expertise contributes directly to improving patients' lives worldwide.

We offer:

8.33% year‑end bonus.

Personal training budget of €2,100 every three years.

Travel expense reimbursement from the first kilometer.

Easy access to the office by public transport with parking space.

Excellent pension scheme through PFZW.

Opportunities for personal growth, innovation, and career development within an expanding international organization.

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