Requirements: English
Company: RBW Consulting
Region: Nice , Provence-Alpes-Cte d''Azur
RBW are currently partnered with an innovative animal health company that are searching for a Pharmacokinetics Scientist to contribute to their development pipeline.
Responsibilities:
- Manage the various pharmacology (PK, PK/PD) studies for the projects you are responsible for, with the aim of obtaining marketing authorization for the products;
- Provide support to the entire group (participation in global development plans, definition of study designs, study conduct and analysis, drafting dossiers and other regulatory materials).
- Use your pharmacological expertise to propose the most effective approach adapted to the project's objectives, both for the exploratory and development phases.
- Propose product development plans to document the PK, PK/PD sections of MA applications, particularly EU and US, while taking into account product registration in other target geographic areas
- Draft PK, PK/PD arguments to support the safety and efficacy sections of MA applications in target countries (particularly the EU and the US) and the documents required for product registration in other territories according to local requirements;
- Act as an expert in Pharmacokinetics and participate in the promotion and dissemination of this expertise
Education and Experience
- Master's or PhD with at least 2 years of experience in the pharmaceutical industry.
- Expertise in pharmacology (PK and PD)
- Mastery of GLP standards and animal ethics
- Understanding of European pharmaceutical regulations in your field of activity
- Good knowledge of WinNonlin pharmacokinetic software
- Experience in PK/PD and PBPK modeling