Regulatory Affairs Expert/Specialist
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 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.
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, we just have released new openings for Regulatory Affairs Specialist/Expert to join our current team of specialists.
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.
Exciting challenge within a highly specialized team of scientists, inst'it?
- Guidance to 2-3 customers on the regulatory requirements for approval of a first in human clinical study
- Writing of the IMPD and IB and submission of the clinical trial application packages in close collaboration with the customers and medicine agencies.
- 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