PERM: Drug Regulatory Affairs Manager - Pharma / Bulgaria

Duties & Responsibilities:

- Preparation of submission documentation (applications for registrations, variations, renewals, burning documents on electronic media, composing cover letters)
- Preparation of local labeling documents - SPC, PIL, labeling; review of packaging materials
- Checks the local regulatory requirements and distributes the information within local RA
- Updates constantly internal regulatory-relevant databases
- Archives necessary documents
- Does anything else requested by direct supervisor (Medical Director) ensuring smooth RA processes in Bulgaria
- Act as a consultant for the Vigilance matters

Requirements:

- Life science degree (medical, paramedical, pharmacy, biochemistry field is preferred)
- At least 1-2 years experience in Regulatory Affairs in Pharmaceutical company or Drug Agency
- Good organizational skills with ability to work diligent, accurate and under pressure, alone or as part of a team
- Good communication skills
- Fluency in Bulgarian and English, both written and spoken

If you are interested in this position or know someone who might be suitable/interested, please feel free to contact me or pass my contact details for further information.

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