REGULATORY AFFAIRS PROJECT MANAGER

Expand Health is a consultancy company operating in the pharmaceutical industry.
Currently we are looking for Regulatory Affairs Project Manager with proven abilities and strong motivation who will be working for a global team but will be based in Sofia.

The selected candidate will be responsible for Life Cycle Management of marketing authorizations, including:

- Planning, preparation and submitting variations to marketing authorizations granted via EU procedures;
- Preparation and timely submission of renewals to marketing authorizations granted via EU procedures;
- Coordination and support of post approval changes and renewals of national licenses;
- Maintenance of relevant regulatory tools;
- Maintenance of communication pathways with all relevant internal stakeholders and external contacts, including Regulatory Authorities, local affiliates, R&D, business and marketing functions.

Necessary skills and background:
- Master’s degree in Life Science, Pharmaceutical or equivalent;
- 3+ years professional experience in regulatory or pharmaceutical industry;
- Experience managing projects and working in international companies will be considered as an advantage;
- High level of written and spoken English;
- Strong working knowledge of MS Office;
- Good organizational skills;
- Proven ability to deliver results.

The selected candidate will enjoy:
- Dynamic and challenging work environment;
- Competitive remuneration;
- Working for an international company with development opportunities.

All information regarding your application will be treated with utmost confidentiality. Only shortlisted candidates will be contacted for an interview.

If you are interested, please, send your CV to yana.karsheva@expand.bg