Principal CMC RA Manager
Principal CMC RA Manager
- - Gent Belgium
Function: Provide support by writing and submitting CMC regulatory documents but also scientific reports for diverse customers & projects.
The company 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.
The company is operating from six sites in Europe. For the company branch based in Gent, Belgium, we are looking for a
Senior Global Regulatory CMC Writer
YOUR KEY ROLE
The company'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 Senior Global Regulatory CMC Writer, next to the writing of quality documentation, your key role is also to prepare and execute Global Regulatory CMC strategies, provide guidance to global 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
Interpret and apply global/regional CMC regulatory guidelines and regulations
Requested competences and skills:
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.
Excellent writing skills
Strong communication skills (both written and spoken), interpersonal and relationship-building skills
Very good knowledge of English is required
Project management skills
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
An attractive and tailor-made remuneration package including extra-legal benefits
Ability to grow your experience and skills in a rapidly growing company with international customer portfolio
A dynamic working environment