Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
Ardena is a rapidly growing international orientated organization with a dedicated team of about 320 professionals operating from 6 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.
We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.
For the Ardena Business Unit based in Ghent, Belgium, we are looking for a
Regulatory CMC Writer
What you will work on
The Dossier Development team brings tailored and timely services to our customers in the very broad sense of regulatory services. We provide support by writing and submitting regulatory documents (e.g. MAAs, IMPDs, variations, etc.) but also scientific reports for diverse customers & projects. At Ardena, we are experts in writing scientific reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout in order to ensure consistency, completeness and readability.
YOUR KEY RESPONSIBILITIES
- Ensure full compliance with regulatory requirements
- Prepare and write CMC dossier-centric scientific reports which will be used as basis for global regulatory submissions (MAA, NDA, BLA)
- Prepare and write the CMC documentation needed for clinical trials (IMPD/IND)
- Interpret and apply global/regional CMC regulatory guidelines and regulations
YOUR PROFILE LOOKS LIKE/ RESEMBLES
Education and experience:
- Master’s degree or Ph. D. in a scientific discipline e.g., pharmacy, biotechnology, bioengineering, biomedical sciences or similar.
- You are familiar with regulatory CMC writing (EU) or you have regulatory knowledge of (bio)pharmaceutical manufacturing and development
- Strong writing skills
- Very good communication skills (both written and spoken)
- Very good knowledge of English is required
- Taking ownership
- Well organized and able to handle multiple projects in parallel
- Ability to work independently and under time-pressure
- You have a proactive attitude, and you dare to think out-of-the box
- Customer-oriented and quality conscious attitude
- Eye for detail
- Proficiency with MS Office (mainly Word, Excel)
- Eager to learn
WHAT WE OFFER
- A true learning environment where you will have the ability to grow your skills
- A rapidly developing and growing international company with an attractive services, product and customer portfolio
- A dynamic working environment with nice colleagues
- Open straightforward but also caring culture
- We are true to our values
- An attractive remuneration package
- Flexible working hours
- 32 days holiday a year
If you like to have more information about the role, please do not hesitate to contact Stijn Maertens, email: HR@ardena.com.
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in Belgium) will not be given a status update.
Agency calls will not be appreciated.