Regulatory Associate
- Ware, Hertfordshire (GBR)
- £25 - £30 Per Hour
- 6 Months
- Start date: ASAP
- Ref: REGASOCI
- product marketing
- regulatory submissions
- documentation
- pharmaceutical
- data mining
- testing
- microsoft word
- collation
- archives
- databases
- vitro
Regulatory Associate
Role initially is working from Home
Job Description – Regulatory Associate Contingent Worker - Department: Nonclinical Regulatory
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 the nonclinical content related to in vivo and in vitro testing: ie pharmacology, pharmacokinetics & toxicology related to drug development
- Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word and Excel.
- Proficiency in searching on-line scientific publication databases.
Preferred qualifications:
Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.
Specific Accountabilities and Responsibilities
This role will assist in the preparation of nonclinical regulatory dossiers including:
· Global CTD dossiers for Marketed Products
· Clinical Trial Applications
Marketed Products: Support for GSK’s extensive portfolio of established products via collation and update, where required, of 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 marketed product dossiers by:
- Data mining and compilation of nonclinical study reports from legacy submissions and company archives
- Updates to specific nonclinical 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 content delivery departments 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 experts and CMC regulatory.
· Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
Environmental Risk Assessments: This role may also support the preparation of ERA documents which are required under the European Medicines Agency Regulation on Marketing Authorization Applications (MAAs), product line extensions, and license variations (EMEA/CHMP/ SWP/4447/00) or as requested by a non-European Union Agency to fulfil country specific requirements.
Other nonclinical regulatory supporting tasks that may be required from time to time.
