Regulatory Affairs Manager
At Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for all!
Thanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background, RLM Consulting, a Univercells affiliate, provides international regulatory affairs support at all stages of product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier for marketing authorization.
Our very experienced staff provides strategic guidance (most appropriate regulatory scenario) as well as practical feedback to drive the development of medicinal products. RLM Consulting, located in Belgium, has a strong experience in writing and negotiating with national agencies and the EMA: briefing documents for scientific advice requests, orphan drug designation dossiers, advanced therapy medicinal status, clinical trial applications (IMPD, IB) and marketing authorization applications with the Authorities.
Currently, due to our global expansion of Univercells's group and many requests we have form customers to help them in their regulatory strategy and negotiation with the FDA agency, we are expanding our activities in the United States. Univercells, our mother company, has open a hub in Boston - Andover, MA, in which we will have Regulatory activities represented by RLM Consulting.
Every person will have the opportunity to contribute to our mission and be impactful. Apply and be part of this great adventure!
Due to our increase in work and international expansion, we just have released new openings for Regulatory Affairs Manager/Expert US based to join our current team.
MISSION:
At RLM, we supports our clients with a range of services from regulatory strategy and regulatory expertise to trainings. We work across a range of product areas from small molecules and biologics to advanced therapy products. As Regulatory Affairs Manager / Lead, you will guide our clients (Biotechs/pharmaceutical companies) to have a chance of getting regulatory approval for their therapies. As regulatory Expert / Lead you have gain a large expertise in Regulatory strategy, in identifying the best regulatory path, in writing and preparing the requested documents needed for dossiers. You are a real expert of FDA regulations.
Exciting challenge within a highly specialized team of scientists.
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 !
