Senior Regulatory Affairs Specialist
||Hybrid (on-site and remote)
|Main Purpose of Job:
||To assist the Regulatory Affairs team, perform regulatory functions (medicinal products for human use, medical devices, food supplements) and provide regulatory support on behalf of client companies.
|Main Duties & Responsibilities:
- perform submissions and timely management of administrative procedures with the local competent authorities (Bulgarian Drug Agency, Bulgarian Food Safety Agency) including preparation of applications, notifications and supporting administrative modules;
- translation of product information, including centrally authorized medicinal products for human use;
- communication with multi-national clients and with the competent authorities;
- keeping clients up to date with local national requirements;
- involvement in trainings and meetings with clients;
- operating under company procedures, work with regulatory trackers and databases.
||Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs for medicinal products for human use. Staying up to date with changing regulatory requirements expected.
- preferably Pharmacist (MSc) or Medical doctor, Life sciences degree (BSc or equivalent) also acceptable;
- minimum 3 years experience in regulatory affairs for medicinal products for human use is required;
- experience in translation (from English into Bulgarian language) of product information for centrally authorized medicinal products is a must;
- pharmacovigilance experience/knowledge would be beneficial;
- excellent learning abilities: promptly achieving/updating working knowledge of EU and national regulatory requirements and procedures is required;
- candidates must be familiar with MS Office;
- excellent written and oral communication skills in English and Bulgarian are required, attention to detail and multitasking ability to follow-up projects, monitor and stay within deadlines is a distinct advantage.
||Dynamic small team and friendly environment. Salary negotiable and commensurate with experience. Trainings provided at national and international level.
||Closing day not set. Please send all applications with CV and cover letter in English language to:
All applications will be treated confidentially and in compliance with the applicable personal data protection requirements. Only prospective candidates will be contacted for an interview.*
* NOTE: no recruitment agency approaches please.