Job description Posted 09 July 2019

Department: Nonclinical Regulatory

This role requires the RA to assist in the preparation of the nonclinical content for various global regulatory dossiers.

Basic qualifications:

• Minimum graduate level, with a relevant biologically based scientific background.

• Understanding of pharmacology, pharmacokinetics & toxicology related to drug development

• Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word.

• Proficiency in searching on-line scientific publication databases.

Preferred qualifications:

Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or Clinical Trials Applications.

Specific Accountabilities and Responsibilities

This role will assist in the preparation of nonclinical regulatory dossiers including:

• Global CTD dossiers for Established Products

• Clinical Trial Applications

Established Products: Support for GSK’s extensive portfolio of established products via update of modular nonclinical regulatory documentation for the purpose of generating dossiers to support a range of global regulatory submissions. This role involves the continued preservation and update of nonclinical components of established product dossiers by:

• Completion of periodic updates of the documents to ensure that they reflect a contemporary understanding of each product.

• 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 Applications: The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications must conform to the regulations and guidance of the authority to which the submission is made. This role involves the efficient production of submission documents such that the correct materials are available at the optimum time by:

• Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates.

• Facilitating construction of nonclinical documentation to support applications in China.

• Responding to requests for nonclinical documentation in a timely manner.

• Coordinating and preparing the nonclinical components of lifecycle documents.

• Comprehensive literature/information searches both externally and internally (specified GSK databases).

• Coordination with other disciplines eg Nonclinical development and CMC.

• Preparation/review of tabular data summaries and study listings tables for ongoing submission support.

Other nonclinical regulatory supporting tasks that may be required from time to time.

Additional information about the process

All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!

Join GSK’s vision to do more, feel better and live longer: