Regulatory Affairs Officer/ Manager APAC
Middle (2-5 years), Senior (5-10 years)
This job can be done remotely
English - Advanced
, Romanian - Advanced
* all languages are compulsory
This job is inactive, but you can still send your resume to the company
ProductLife Group is looking for a Regulatory Affairs Officer/ Manager APAC 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. We are looking for Regulatory Affairs Manager due to an increase in workload.
- 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 Officers and Associates.
- Assist the RA Platform / Hub Leader or a Senior RA consultant in presales:
- Ensure providing technical support to presales.
- Ensure adequate technical description of the proposals and support sales for quotation evaluation.
- Provide in-house training as required for staff in the Regulatory Affairs group.
- Contribute to the production of client documents and reports.
- Support the Pharmacovigilance group in the production of Regulatory Authority documentation.
- Bachelors’ Degree or higher graduate degree in a life science related field.
- At least 3-5 years’ experience in Regulatory Affairs, in the pharmaceutical industry or service providence.
- Knowledge of ASEAN, Australia, New Zealand, and China would be a plus.
- Fluent in English for daily internal and external contacts. Chinese Mandarin would be a plus.
- Ability to work on several different activities and projects.
- Excellent problem solving skills.
- Good organizational skills and rigor in work.
- Knowledge of APAC registrations is mandatory.
- Knowledge of EDMS and Regulatory databases (Register).
- 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.