Regulatory Affairs Expert
il y a 1 jour
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.
Currently, due to our global expansion of Univercells's group and many requests we have form customers to help them in the negotiation with the FDA agency, we are expanding our activities in the United States. Univercells has open a hub in Boston - Andover, MA, in which we will have Regulatory activities represented by RLM Consulting.
Due to our increase in work and international expansion, we just have released new openings for **Regulatory Affairs Specialist/Expert** **US based** to join our current team of specialists.
**MISSION**:
At RLM, we supports our clients with a range of services from regulatory strategy and expertise to trainings. We work across a range of product areas from small molecules and biologics to advanced therapy products. As **Regulatory Affairs Specialist/Experts**, you will guide our clients (Biotechs/pharmaceutical companies) to have a chance of getting regulatory approval for their therapies. You are an expert of FDA regulations.
Exciting challenge within a **highly specialized team of scientists,** inst'it?
**RESPONSIBILITIES**:
- Guidance to 2-3 customers on the regulatory requirements for approval of a first in human clinical study
- Writing, submission, follow-up of Orphan Designation requests to the EMA and the FDA
- Writing, submission, follow-up of scientific advices/interact meetings requests to EMA and FDA
**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); a good command in French and other European 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?
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