- Create scientific and technical documents (protocols, reports, assessments, etc.) related to drug substance, drug product, and analytical development for new chemical entities and biological products, potentially for global regulatory submissions.
- Develop the quality section of clinical trial applications and marketing applications.
- Hold a Masters degree in a scientific field (e.g., pharmacy, biotechnology, biomedical sciences, chemistry, or similar).
- Display a passion for scientific and technical writing in chemical and biopharmaceutical areas.
- Show a keen interest in regulatory standards.
- Familiarity with drug development is advantageous.
- Demonstrate excellent communication skills (both written and verbal).
- Be proficient in written and spoken English.
- Possess strong scientific writing abilities.
- Show attention to detail and precision.
- Have a willingness to learn and the capacity to work autonomously when required.
- Exhibit proficiency in MS Office applications, specifically Word and Excel.
- Display problem-solving capabilities paired with a quality-focused approach.
- Be well-organized and capable of thriving in a dynamic setting.
- Engage in the development of novel drugs.
- Access a supportive learning atmosphere for skill enhancement.
- Be part of a rapidly growing international organization with diverse services, products, and clientele.
- Enjoy a dynamic workplace alongside friendly and cooperative colleagues.
- Experience an open, direct, and supportive corporate environment.
- Receive an attractive remuneration package.
- Benefit from flexible work hours and potential telecommuting options.
- Avail a generous annual leave allowance of 32 days.
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Associate CMC Regulatory Scientist - Ghent, België - Ardena
Beschrijving
About our Company
As a prominent contract development and manufacturing organization (CDMO) in the pharmaceutical sector, Ardena is committed to aiding pharmaceutical companies, from emerging biotechs to major players, in advancing their valuable molecules to the market. Our dedication involves offering a comprehensive range of services covering drug substance and drug product development, manufacturing, logistics, and bioanalytical services.
With a swiftly expanding international focus, Ardena proudly houses a team of 500+ professionals spread across five strategically positioned locations. Our footprint extends across Belgium (Gent), The Netherlands (Oss and Assen), Spain (Pamplona), and Sweden (Södertälje). Embracing a transparent and welcoming work culture, we prioritize team spirit, an open mindset, and ownership within our organization.
We are a driving force in drug development, presenting exciting career opportunities to talented and driven individuals looking to leave their mark in the rapidly growing global pharmaceutical industry. If you aspire to excel in a challenging contract research and development environment, working alongside experts to innovate drugs for unmet medical needs, Ardena could be the perfect fit for you.
For the CMC Regulatory Team at Ardena's base in Gent (Belgium), we are currently seeking an
Associate CMC Regulatory Scientist
Key Responsibilities
Your Profile
Education and Interests
General Skills
What We Offer
Join us in shaping the future of regulatory drug development and become a valuable part of a team that esteems your contributions and personal development. Take the step towards an exciting journey with us.
