Senior Regulatory Affairs Manager with Hungarian
Middle (2-5 ani), Senior (5-10 ani)
engleză, maghiară, română
ProductLife Group is looking for a Senior Regulatory Affairs Manager with Hungarian 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.
As a result of a new project we are now seeking a Senior Regulatory Affairs Manager responsible for ensuring the delivery of regulatory activities performed on the RA Platform/the DE Hub. Regulatory activities include pre-licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.
We are looking for someone with proven understanding of the regulatory processes and experience in leading projects successfully, excellent organisational and interpersonal skills and the ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in Hungarian and English.
- 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.
- 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
- Control that invoicing is correctly set.
- Contribute to data entry in PLG tools enabling measurements and measure KPI/metrics for regulatory services supplied by the platform/hub.
- Produce and review SOPs relating to the Regulatory Affairs function.
- Participate in trainings as required.
- 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 and Ethics Committee documentation.
- Liaise with other group companies on regulatory issues and to provide support for their activities in the regulatory field.
- Contribute to follow up of the quality of service of regulatory partners working with the Platform/the Hub.
- Represent PLG in regulatory associations, events and congress.
- Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
- Master’s degree in a life sciences related field, or equivalent experience
- Minimum 5 years of experience in a regulatory affairs department/pharmaceutical industry (This experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion);
- Knowledge of EU and German registration;
- Cross functional communication and presentation skills;
- Local Pharmacovigilance experience;
- Experience in Labelling in Germany;
- Effective oral and written communication skills in Hungarian and English;
- Ability to work well within a team;
- The ability to co-ordinate, manage and motivate a team;
- Process orientated with good attention to detail;
- Excellent organisational and interpersonal skills.
- Full training on the job and external courses will be provided;
- Competitive salary package;
- Dynamic environment with opportunities for advancement within the company or the wider group;
- International and growing company;
- Flexible working environment;
- Health insurance;
- Meal tickets.