The Acquisition of Pharma IT Will Enable PLG to Strengthen its Foothold in Northern Europe and Offer New Services in the Context of Life Sciences Digitilisation
In the context of a new project, we are looking for our next Regulatory Affairs Officer to join our teams.
Responsibilities
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Gain regulatory authority approval
Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
Provide regulatory support to clients and associate companies
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
Profile
Bachelor’s or higher graduate degree in a science related field, or equivalent experience.
2 to 5 years of experience in a regulatory affairs department required
Relevant experience in International region regulations (can be MENA, Africa, APAC etc..)
Excellent organizational and interpersonal skills
Ability to work well within a team
Process orientated with good attention to detail
Effective oral and written communication skills in English
Good computer skills and the ability to learn appropriate software (eDMS, MS Word, MS Excel)