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 services.
Ardena is a rapidly growing international orientated organization in the industry, with 6 company sites in 4 countries. (Belgium, the Netherlands, Latvia and Sweden). Each Business Unit has its specialization. The organizations specialties are complementary to each other and created One Ardena Group. We currently have over 320 people working for us and have realized an average growth of 15% on annual basis over the past 3 years. We are ambitious! For you the possibility to expand your knowledge, grow and develop with us.
For the Ardena DD Business Unit based in Ghent (Belgium), we are looking for a
Global Regulatory CMC Manager
WHAT YOU WILL WORK ON
Ardena’s 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 CMC regulatory documents (e.g. MAAs, IMPDs, variations, etc.) but also scientific reports for diverse customers & projects. As a Global Regulatory CMC Manager, next to the writing of quality documentation, your key role is to prepare and execute Global Regulatory CMC strategies, provide guidance to project teams for (bio)pharmaceutical projects in early development stages, and represent global reg-CMC in projects teams.
YOUR KEY RESPONSIBILITIES
- Ensure full compliance with regulatory requirements
- Stay up to date with global regulatory guidelines and regulations
- Prepare and write CMC regulatory documentation for new filings (MAA, NDA, BLA) and clinical trials (IMPD/IND)
- Prepare post-approval variations (EU, FDA and International)
- Determine regulatory CMC strategies, assess possible risks, and set up contingency plans
- Resolve issues and manage regulatory risks and ambiguous situations within project teams
- Coach other CMC writers with the regulatory documentation
- Interpret and apply global/regional CMC regulatory guidelines and regulations
- Have frequent contact with customers and Regulatory agencies
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.
- At least 5 years of experience in the industry
- You are an experienced regulatory CMC professional (EU and/or US) or you have regulatory expertise in (bio)pharmaceutical manufacturing and development
- Experience with regulatory requirements in Canada, Japan, China and RoW is a plus.
- QA experience is a plus.
- Fluency in English writing, a second language is seen as a plus.
- Excellent writing skills
- Strong communication skills (both written and spoken), interpersonal and relationship-building skills
- Project management skills
- You love to coach others and transfer your knowledge
- You are pro-active and are used to have ownership
- Well organized and able to handle multiple projects in parallel
- Ability to work independently and under time-pressure
- 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 International developing and growing company with an interesting 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: firstname.lastname@example.org.
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.