Overview

KRKA Pharmaceutical Factory is looking for a candidate for the position of Regulatory Associate. The incumbent will be responsible for obtaining marketing authorizations in compliance with legislation and regulations. He/ she will also be responsible for gathering, processing, distributing and archiving information, data and documentation as well as maintaining databases. The Regulatory Associate will perform tasks in the assigned field related to professional informatics and information data and documentation systems in line with the legislation and regulations.

Responsibilities:

- Monitor and manage product registration regulations;
- Prepare regulatory activity plans for individual products;
- In cooperation with expert departments at KRKA, prepare the registration documentation and translations in Armenian language;
- Submit registration documentation to the relevant state institutions in order to be granted marketing authorization as soon as possible;
- Conduct registration procedure supporting it during all phases;
- Provide ongoing information about problems in obtaining marketing authorization (in writing);
- Participate in the organisation and/ or realization of documents and text translations into Armenian language;
- Check and make corrections of packaging materials written in Armenian language intended for submission to regulatory authorities and before final print;
- Organize, provide guidance and keep records on receipt, distribution and archiving of internal and external documentation, information and data;
- Keep the database and documentary records on the registration procedures and distribute relevant data concerning the marketing authorizations;
- Set up and maintain the information system for the entire product range in the territory;
- Monitor, analyse and assess work results;
- Submit the pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilance;
- Conduct tasks in compliance with rules from the fields of quality assurance, occupational health and safety, and fire safety;
- Perform all other tasks assigned by superiors and consistent with employee's qualifications and needs of the work process.

Required Qualifications:

- Higher pharmaceutical or medical education;
- Work experience is an advantage;
- Knowledge of Armenian, English and Russian languages;
- Ability to work effectively in a team;
- Excellent interpersonal, communication and networking skills;
- Computer skills (MS Word, MS Excel, MS Outlook and MS PowerPoint).