To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval
Gain regulatory authority approval
Provide regulatory support to clients and associate companies
Assess regulation and inform the clients about the impact on their products or activities
Liaise with sponsor head-office and affiliate departments on regulatory issues. Liaise with external regulatory authorities as required
Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
Review tasks for, support and mentor Regulatory Affairs Associates
Provide on-going regulatory support to the Regulatory Affairs Team Lead 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 and metrics for regulatory services supplied by the platform/hub
Control that invoicing is correctly set
Assist the RA Platform or Hub Leader or Coordinator in presales:
Ensure providing technical support to presales
Ensure adequate technical description of the proposals and support sales for quotation evaluation
Ensure that invoicing is done correctly

PROFILE

Master or higher graduate degree in a science related field, or equivalent experience
Min of 3-5 years of experience in a regulatory affairs department required + relevant experience in EU regulations
Strong coordination skills and leadership
Client communication and facing experience
Excellent communication skills in English (written fluency a must, verbal fluency preferred)
Excellent organisational and interpersonal skills
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
Ability to work well within a team
Process orientated with good attention to detail
Sense of responsibility and meeting deadlines
Pro-active attitude and able to work on own initiative as well as part of a team
Ability to prioritise different workloads/multi-task
Personal responsibility for ensuring a high standard of work

Imprimer