Regulatory Affairs Officer (Chemistry) with French
Entry (0-2 years), Middle (2-5 years)
This job can be done remotely
English - advanced, French - advanced, Romanian - advanced
ProductLife Group is looking for an Regulatory Affairs Officer (Chemistry) with French in Cluj-Napoca!
ProductLife Group 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 ProductLife Group’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.
- Regulatory compliance tasks.
- Variation preparation and CMC writing.
- Liaise with external regulatory authorities as required.
- Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams.
- Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub.
- Contribute at the production of the client administrative documents and reports to be included in regulatory submissions.
- Bachelor’s or higher graduate degree in a science related field, or equivalent experience with a training in CMC writing / variation files.
- At least 2 years of experience in regulatory affairs department (Chemical product, Medical Device, Biotech, Biologics).
- Good knowledge of regulatory procedures (EU/ France).
- Knowledge in CMC.
- Analytical chemistry or formulation is an asset.
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel.
- Experience in CMC writing (Variation package) is a plus.
- Process oriented.
- Ability to work well within a team.
- Excellent organizational and interpersonal skills.
- Fluent in English and French is mandatory and any other European language is a plus for daily contacts with local and international partners.
- Full training on the job.
- Competitive salary package, with medical subscription and meal tickets.
- Dynamic environment with opportunities for advancement within the company or the wider group.
- International and growing company.
- Flexible working environment.