International Regulatory Affairs Assistant - France
- Our company is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services.
- All our company’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes
- As a result of the deployment of a new project we are now seeking an International Regulatory Affairs Assistant
- To contribute to the production of client administrative documents to be included in regulatory submissions
- Compile regulatory dossiers in accordance with requirements.
- Systems Management and Administration
- Document and track regulatory submissions and regulatory authority approval.
- Provide regulatory support to clients and associate companies.
- Liaise with sponsor head-office and affiliate departments on regulatory issues.
- Liaise with external regulatory authorities as required.
- Provide review of packaging texts.
- Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labeling (e.g. QRD compliance check).
- Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
- Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- Assist in the management of company's Quality Management System.
- To participate in training as required for company staff.
- Support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation.
- Liaise with external regulatory authorities as required, notably in case of technical invalidation.
- To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
- Education: Bachelor’s degree in a science related field
- Experience: 1 year minimum of work experience in International Regulatory Affairs Pharma products
- Excellent organisation skills.
- Effective oral and written communication skills
- Good computer skills and the ability to learn appropriate software
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
- You are fluent in English and French (spoken and written) for daily contacts with local and internationally partners
- Good interpersonal skills
- The ability to work well within a team
- Process orientated with good attention to detail
- Competitive salary package
- Training and development
- International and growing company
- Dynamic environment