Regulatory Affairs Manager

il y a 1 semaine


Charleroi, Wallonie, Belgique Univercells Temps plein

RESPONSIBILITIES

:

Guidance to some customers on the regulatory requirements

Writing, preparation of dossier for regulatory submissions like ANDA, Type B/C, BLA, Breakthrough Designation, Interact/fastrack,...

Writing and submission of the pre-IND and/or IND, in close collaboration with the customers and FDA.

Writing, submission, follow-up of Orphan Designation (ODD) requests to the FDA

Writing, submission, follow-up of briefing documents/interact meetings requests to FDA

Liaise and negotiate with global authorities or FDA authorities

REQUIREMENTS:

Master/PhD in Biology/Bio-Medical Sciences/Chemistry or Industry Pharmacist or Bioengineer.

Well-organized, flexible, rigorous, dedicated. Team spirit.

Fluency in English (oral, written). Any other languages are a plus.

Ideally a minimum 5 years in regulatory guidance and dossier writing in pre-marketing medicinal product development.

Very strong know-how of FDA requirement and legislation.

OUR OFFER:

We offer a long-term contract, a competitive salary package and the possibility of evolution in an international, dynamic, and fast-growing company.

Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now


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