That's XPE. For one of our clients we are looking for: RA Assistant Organisation description:
Our client is looking for a RA Assistant. (Regulatory Affairs) With 94 million patients treated worldwide by the medicinal products on a daily basis, our client is keenly aware of their responsibilities to patients, doctors, and healthcare professionals. They are the motivating force behind the daily drive for innovation as a provider of therapeutic progress.
Their ambition is for you to experience a long-term relationship of trust that will encourage you to express your qualities and further develop your skills. Starting with an individually tailored induction program, you can share what you are passionate about with teams committed to therapeutic progress for the benefit of patients. You can build a rich and varied professional career. This company is involved at each stage of the drug chain and brings together all professions in research and development, production, and promotion, as well as cross-functional activities. You can join a working environment in which goodwill and the pleasure of working together take priority. They're currently reinventing themselves so as to better fulfill their corporate purpose and help provide future generations with a world where quality health care is available to all. When you join this group, you become one of the driving forces of this purpose! They are committed to therapeutic progress to serve patient needs with the help of healthcare professionals. They strive to provide future generations with a world where quality healthcare is available and accessible to all.
Their 4 values:
"Dare to innovate - We undertake to provide innovative therapeutic solutions. Driven by a pioneering spirit, we dare, we strive, and we accomplish together.
Care - We prepare for the future by embracing human and environmental dimensions. Our concern for the health and fulfillment of all is our driving force.
Grow by sharing - Every opportunity to work together contributes to the common good. Whoever we are, wherever we are, we grow and develop by working together, building on one another's experiences and contributions.
Commit to succeed - The continuous development of the Group is vital. Whatever challenges we face, we are committed to keeping our promises."
Regulatory Affairs departmentJob description:
- Ensuring updates of SPC in affiliate Access
- Ensuring updates of trainings in Electra
- Ensuring updates in COSAC
- Ensuring updates in Register (implementation of submission dates, approval dates, formulations and packagings)
- Ensuring updates in Ereca (adding of official documents)
- Ensuring updates in EVMPD
- Ensuring updates in e-compendium
- Preparation of the translation process (FR,NL, DE) of the SPC & PIL impacted by variations
- To assist RAM for administrative tasks for preparation of RMA materials, DHPC letter, distribution and tracking.
- Creation and modification of artwork of packaging materials in COSA
- Preparation of CPP's
- To assist RAM in other administrative tasks
- To assist the Responsible pharmacist GDP in administrative tasks (quality complaints)
- Follow up of codification article table
- Preparation of order forms and reception of JDE system
- Regular verification of Belgian Agency (AFMPS) internet site, European Medicine Agency (EMA), Official Journal MB
-Experience in Regulatory Affairs is a must;
-Excellent language knowledge of Dutch and French, German is welcome
-Excellent analytical, communication and organizational skills.
Fix contract with interesting advantages
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713