Regulatory Affairs Manager

12/04/21

Location

Ghent

Function type

Regulatory Affairs

Vacancy

The Polymer Chemistry & Biomaterials Group of Ghent University developed a novel class of modified gelatins allowing photo-crosslinking for various biomedical applications.

For a spin-off project, a minimally invasive injectable is being developed to improve lipofilling applications. To this end, they have been joining forces with the Department of Plastic and Reconstructive Surgery (University Hospital Ghent).

In order to strengthen their team and move forward, they are looking for a person managing the regulatory dossier.

Regulatory Affairs Manager

Your key role

Manage the complete regulatory approval process required to commence with clinical trials

Your key responsibilities

  • Ensure full compliance with regulatory requirements.

  • Stay up to date with global regulatory guidelines and regulations.

  • Interacting with Health Authorities.

  • Prepare and write the STED (Summary Technical documentation) files for demonstrating conformity to the essential principals of safety and performance of our Gelinject product, a class III medical device.

  • Manage Biological Risk analysis, stability studies and biocompatibility testing together with external consultants

  • Determine regulatory strategies, assess possible risks, and set up contingency plans

  • Resolve issues and manage regulatory risks and ambiguous situations within project teams

Your profile

Education and experience

  • Master’s degree or Ph. D. in a relevant scientific discipline e.g., pharmacy, biotechnology, bioengineering, biomedical sciences or similar.

  • Experience in the industry is a plus, yet not a strict necessity

  • You are an experienced regulatory professional or you have regulatory expertise in (bio)pharmaceutical manufacturing and development

General Skills

  • 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

  • Taking ownership

  • Problem-solver

  • 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

  • Eye for detail

  • Proficiency with MS Office (mainly Word, Excel)

  • Eager to learn

We offer

  • Competitive salary according to Ghent University policy (see Salarisschaal postdoctoraal medewerker (WP) — Universiteit Gent (ugent.be))

  • Ability to grow your experience and skills in a rapidly growing start-up company with international customer portfolio

  • A dynamic working environment

If interested, please contact us and send us your cv and motivation letter via email to:
Sandra.vanvlierberghe@ugent.be

Job application