Associate CMC Regulatory Scientist

About Ardena

As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio covering drug substance and drug product development, manufacturing, logistics, and bioanalytical services.

With a rapidly growing international orientation, Ardena boasts a team of 500+ professionals operating across five strategically located sites. Our presence spans Belgium (Gent), The Netherlands (Oss and Assen), Spain (Pamplona), and Sweden (Södertälje). Embracing an open and transparent culture, we hold team spirit, an open mindset, and ownership as key values within our organization.

We are a dynamic force in drug development, offering compelling career opportunities to skilled and motivated individuals seeking to make their mark in the rapidly expanding global pharmaceutical industry. If you're looking to thrive in a challenging contract research and development environment, collaborating with experts to innovate drugs for unmet medical needs, Ardena could be the ideal workplace for you.

For the Ardena CMC Regulatory Team based in Gent (Belgium), we are looking for an

Associate CMC Regulatory Scientist

The CMC Regulatory team is dedicated to delivering customized and timely regulatory drug development services to our valued customers. Our support spans all aspects of Chemistry, Manufacturing & Control (CMC) writing activities across various stages of the drug development process. We collaborate closely with other Ardena teams, providing regulatory CMC advice throughout drug development and dossier submission.

Position Overview:

As an Associate CMC Regulatory Scientist, you will play a pivotal role in the drug development process by contributing to the creation of qualitative documents. This entry-level position offers a fantastic opportunity to collaborate with experienced colleagues and gain firsthand experience in the dynamic field of regulatory affairs.

Key Responsibilities:

• Write and compile scientific and technical documents (protocols, reports, assessments, etc.) related to drug substance, drug product, and analytical development for both new chemical entities and biological products. These documents may be used as basis for global regulatory submissions (clinical trial applications, marketing applications, etc.)

• Write and compile the quality section (Module 3) of clinical trial applications and marketing applications.

Your Profile:

Education and Interest:

• Master’s degree in a scientific discipline (e.g., pharmacy, biotechnology, biomedical sciences, chemistry, or similar).

• Passion for scientific and technical writing for chemical and biopharmaceutical products.

• Strong interest in regulatory guidelines.

• Knowledge in drug development is considered a plus.

General Skills:

• Excellent communication skills (both written and spoken).

• Fluent in written and spoken English.

• Strong scientific writing skills.

• Attention to detail and accuracy.

• Eager to learn and ability to work independently when necessary.

• Proficient in MS Office (primarily Word and Excel).

• Problem-solving skills with a quality-conscious attitude.

• Well-organized with the ability to work in a dynamic environment.

What We Offer:

• Opportunity to contribute to the development of new drugs.

• A supportive learning environment for skill development and growth.

• Involvement in a rapidly growing international company with an intriguing services, product, and customer portfolio.

• Dynamic working environment with friendly and collaborative colleagues.

• Open, straightforward, and caring company culture.

• Attractive remuneration package.

• Flexible working hours and the possibility for partial telework.

• Generous annual leave entitlement of 32 days.

Join us in shaping the future of regulatory drug development and be part of a team that values your contributions and personal growth. Apply now and embark on an exciting journey with us!

For more information about the role, please contact Stijn Maertens. Email: HR@ardena.com, Tel: +32 (0) 9 267 65 00.