Regulatory Affairs Specialist |
Evropa Konsult is leading Bulgarian recruitment agency - provider of highly skilled professionals; we are unique in our commitment to delivering the highest quality service through placing the best people.
We support private sector organisations by placing the best talent in the following sectors: Medical, Pharmaceutical, Engineering, BPO, Finance, IT, Sales, Marketing and Administration. We recruit for permanent, temporary and contract roles.
On behalf of our client, multinational Pharmaceutical company, we are looking for:
Regulatory Affairs Specialist
Responsibilities
- Prepare complete documentation for submission of medicines for Bulgaria and abroad, according to the regulatory requirements of the relevant market.
- Preparation and timely submission of renewals for authorisation ;
- Answer questions, remarks and comments related to evaluation of registration documentation by Regulatory Authorities;
- Insuring the confidentiality of the scientific data from the authorization documents
Requirements:
- University Degree - Chemistry, Pharmacy, Biotechnology, Medicine;
- Perfect knowledge of the structure of the registration dossier and the requirements in the European Union regarding the registration documentation;
- Knowing the processes of drug development and manufacture;
- At least 2 years of experience in the Registration Department at a pharmaceutical company;
- Perfect level of English language. Knowledge of Russian language will be considered as advantage;
If that’s the right role for you, please apply by sending up to date copy of your CV.
Only short listed candidates will be invited for interview. All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection.
Recruitment licence from National Agency of Employment №1801 issued on 19.11.2014г. |
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