regulatory affairs manager
Sep 18, 2026 · Bennett Pharmaceutical industry
What you'll do
- Handle Marketing Authorization new applications, variations, and renewal procedures in EU/Non-EU through MRP, DCP, CP, NP
- Communicate with Authorities and third parties for successful project registration
- Manage dossier life-cycle and appropriate archiving
- Review Quality Part of dossier (Module 3)
- Review batch manufacturing documents, stability results, process validation protocols, and reports
- Compile Module 2-3 of a dossier for submission
- Prepare Module 1 documentation for MA applications
- Use eCTD manager for regulatory submissions
- Compile scientific responses to deficiencies raised by regulatory agencies worldwide
- Monitor and review EMA and ICH guidelines regarding quality aspects of pharmaceutical products
Key requirements
- 3+ years' experience
- Handling of Marketing Authorization new applications and variations via MRP, DCP, CP, NP
- Communication with Authorities and third parties
- Dossier life-cycle management, archiving, and use of eCTD manager
- Review of Quality Part of dossier (Module 3), batch documents, stability, and process validation
- Compilation of Module 1 and Modules 2-3 of dossiers for submission
- Good knowledge of EU regulatory legislation and EMA and ICH guidelines
- Oral and written communication in English
- Advanced Computer skills (Word, Excel, PowerPoint)
- Team working spirit and critical thinking
- Life Sciencespreferred
Benefits
- Competitive remuneration, private medical insurance, friendly working environment, career development opportunities.
About the job
Bennett Pharmaceutical Industry is a 100% Greek company, which is active in the whole spectrum of the pharmaceutical industry. We produce high quality generic and original formulations, investing in Research & Development, Innovation, and new technologies. For this reason, Bennett has established…
About the company
Bennett Pharmaceuticals Industry is a 100% Greek company, which is active in the whole spectrum of the pharmaceutical industry. We produce high quality generic and original formulations, investing in Research & Development, Innovation and new technologies. For this reason, Bennett has established itself as the fastest growing company in the pharmaceutical market. Our firm commitment is to offer quality and effective medicines. Having the patient at the center of our activities, we aim to find therapeutic solutions based on innovative ideas and state-of-the-art technologies. Bennett Pharmaceuticals sector covers key therapeutic categories such as Cardiology, Psychiatry, Endocrinology, Pulmonology, Neurology etc. The company also operates in the OTC, medical devices and nutritional supplement areas.
About the company
Bennett Pharmaceuticals Industry is a 100% Greek company, which is active in the whole spectrum of the pharmaceutical industry. We produce high quality generic and original formulations, investing in Research & Development, Innovation and new technologies. For this reason, Bennett has established itself as the fastest growing company in the pharmaceutical market. Our firm commitment is to offer quality and effective medicines. Having the patient at the center of our activities, we aim to find therapeutic solutions based on innovative ideas and state-of-the-art technologies. Bennett Pharmaceuticals sector covers key therapeutic categories such as Cardiology, Psychiatry, Endocrinology, Pulmonology, Neurology etc. The company also operates in the OTC, medical devices and nutritional supplement areas.