Global Regulatory CMC Manager

  • Ghent, BE
  • 8 months ago

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 branch based in Mariakerke (Gent, Belgium), we are looking for a

Global Regulatory CMC Manager

Your key role

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 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
  • 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

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.

General Skills:

  • 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
  • Problem-solver
  • 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

We offer

  • 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 International working environment
  • A learning environment

If interested, please contact us and send us your cv and motivation letter via our website ardena.com/careers or email at hr@ardena.com