ESSENTIAL: Nonclinical pharmaceuticals. Regulatory support. Dossier creation. Global Markets. Life Cycle Management. Mature portfolio. Pharmacokinetics, toxicology, pharmacology. Clinical trials.
2 new vacancies in the Pharmacokinetics department of a bluechip pharmaceutical company are now available. My client requires experienced Regulatory Affairs professionals to join their dynamic, nonclinical team to contribute to the preparation for various mature regulatory dossiers and subsequent life cycle management.
- Preparation of nonclinical regulatory dossiers including: Global CTD dossiers for Established Products, Environmental Risk Assessments (ERA), Clinical Trial Applications
- Compilation of specific CTD components from existing submission documentation
- Comprehensive literature/information searches both externally and internally (specified GSK databases)
- Where necessary, technical authoring of new CTD components to support in?licensed/collaborative products
- Generation of nonclinical submission components to support established pharmaceutical products eg Label unification, ad hoc requests for information
- Collaboration with nonclinical development and regulatory groups
- Clinical Trial application regulatory management.
The Successful Candidate shall:
- Possess a Bachelor’s degree minimum, within a relevant biologically based scientific background.
- Understanding of drug development process from early development to lifecycle management
- Have thorough understanding of pharmacology, pharmacokinetics & toxicology related to drug developmen
- Have excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word
- Be proficient in searching on-line scientific publication databases.