| Job Title: |
Regulatory Affairs Specialist
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| Location: |
Sofia, Bulgaria |
| Job Type: |
Full time, on-site |
| Reporting to: |
RA Team Lead |
| Main Purpose of Job: |
To become part of our Regulatory Affairs team of experts and lead regulatory projects related to medicinal products for human use, medical devices, and food supplements, and to provide regulatory support on behalf of our clients. |
| Main Duties & Responsibilities: |
- Manage submissions and ensure timely completion of administrative procedures with the local competent authorities (Bulgarian Drug Agency, Bulgarian Food Safety Agency), including preparation of applications, notifications and supporting administrative modules;
- Translate product information from English into Bulgarian and vice versa for medicinal products for human use, instructions for use for medical devices, and product labels and leaflets for food supplements;
- Review promotional materials for medicinal products and medical devices to ensure compliance with applicable legislation and internal procedures;
- Communicate with multinational clients and with the competent authorities;
- Provide strategic local regulatory advice to clients;
- Participate in training sessions and meetings with clients;
- Work under company procedures, trackers and databases.
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| Other Responsibilities: |
Responsibilities may vary depending on the nature and scope of the assigned projects. These will primarily relate to Regulatory Affairs activities for medicinal products for human use. The role requires maintaining up-to-date knowledge of changing regulatory requirements and legislation. |
| Skills/Experience: |
- Preferred qualifications include a Pharmacist (MSc) or a Medical Doctor; a Life Sciences degree (BSc or equivalent) is also acceptable;
- Minimum 2 years’ experience in regulatory affairs for medicinal products for human use, medical devices and food supplements is required;
- Experience in translating product information (from English into Bulgarian) is mandatory;
- Excellent written and verbal communication skills in both English and Bulgarian are expected;
- Candidates must have a working knowledge of MS Office;
- Excellent learning abilities: promptly achieving and updating working knowledge of EU and national regulatory requirements and procedures is essential;
- Strong attention to detail, with the ability to manage multiple tasks, follow up on projects, and meet deadlines;
- Experience in translations of product information and support during linguistic review for Centralized Products is an advantage.
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| Benefits: |
- Dynamic small team of experts and a friendly environment.
- Transparent model of task assignments and collaborative support within the team.
- Competitive salary commensurate with experience.
- Professional development support.
- Trainings provided at national and international level.
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| Closing Date: |
February 28th, 2026.
Please send all applications with a CV and a motivation letter in English language.
All applications are treated confidentially and in compliance with the applicable personal data protection requirements. Only prospective candidates will be contacted for an interview.*
jobspharmdedict.com.
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* NOTE: no recruitment agency approaches please.
