Specialist Regulatory Affairs CH&EU Development 100% (f/m/d)
Zurich / Oerlikon, International/Corporate
Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.
We are currently looking for a highly motivated and qualified Specialist Regulatory Affairs Development to support the Regulatory Affairs CH & EU department with the registration of new products.
Your main responsibilities include:
- Completion of low-risk regulatory assignments under supervision.
- Assistance in preparation (including index of changes, statements, completion of eAF), compilation and submission of high quality regulatory applications in compliance with EU and Swiss requirements.
- Preparation of electronic submission files in DocuBridge and submission via CESP (EU) and the portal of Swissmedic (CH) and MHRA (UK) and submission of Clinical Trial Applications.
- Responsible for messaged data to the EudraVigilance portal of EMA.
- Post-approval upload of product information texts to health authority web-portals in the EU, CH and the UK.
- Check of reference medicinal product information texts on health authority web-portals.
- Track the status of applications under regulatory review and provide updates to the regulatory team or other internal/external stakeholders.
- Schedule meetings with internal stakeholders and regulators; develop and organize materials for these meetings.
- Maintenance of internal systems, databases and data for regulatory tracking and reporting purposes. Sharing of information on regulatory requirements with other departments and stakeholders
- Provide regulatory support to project teams, stakeholders and customers, as required.
- The employee will perform other tasks under the direction of the Manager within the agreed type of work.
- Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry
- Up to 2 years of regulatory experience in relevant discipline, jobholder can be a beginner of the job.
- Knowledge of regulatory requirements, process, procedures & pathways.
- Knowledge of clinical development, pharmacovigilance and product life cycle management
- Good communication skills, both verbal and written, with a passion for accuracy and attention to detail.
- Very good interpersonal skills – ability to interact effectively with a diverse group of people from different functions, of different nationalities and at different levels within the company.
- Good project management skills – ability to manage and measure work by reflecting resources, goals and by keeping high performance.
- Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
- Good written and oral knowledge of English
- Acts in line with ACINO principles and values.
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we look forward to hearing from you!
Please send your application documents in English.
Only direct applications are considered. No agencies please.