Requirements: English
Company: RBW Consulting
Region: Nice , Provence-Alpes-Cte d''Azur
RBW are currently partnered with an innovative animalhealth company that are searching for a Pharmacokinetics Scientistto contribute to their development pipeline. Responsibilities: -Manage the various pharmacology (PK, PK/PD) studies for theprojects you are responsible for, with the aim of obtainingmarketing authorization for the products; - Provide support to theentire group (participation in global development plans, definitionof study designs, study conduct and analysis, drafting dossiers andother regulatory materials). - Use your pharmacological expertiseto propose the most effective approach adapted to the project''sobjectives, both for the exploratory and development phases. -Propose product development plans to document the PK, PK/PDsections of MA applications, particularly EU and US, while takinginto account product registration in other target geographic areas- Draft PK, PK/PD arguments to support the safety and efficacysections of MA applications in target countries (particularly theEU and the US) and the documents required for product registrationin other territories according to local requirements; - Act as anexpert in Pharmacokinetics and participate in the promotion anddissemination of this expertise Education and Experience - Master''sor PhD with at least 2 years of experience in the pharmaceuticalindustry. - Expertise in pharmacology (PK and PD) - Mastery of GLPstandards and animal ethics - Understanding of Europeanpharmaceutical regulations in your field of activity - Goodknowledge of WinNonlin pharmacokinetic software - Experience inPK/PD and PBPK modeling