PharmaPath, a Greek pharmaceutical company with a rich history and significant legacy in the pharmaceutical field of generic medicines, is seeking a dedicated and skilled Regulatory Affairs Specialist to join our dynamic team. 

Main responsibilities:

• Support, planning and coordination of all activities needed for the registration process of pharmaceutical products developed by PharmaPath in non-EU territories, according to local requirements.
• Communication with clients for the preparation of the documentation needed for submission and approval of Marketing Authorization Applications, variations, and renewal procedures in non-EU territories.
• Communication with API and FP manufacturers for documents and information needed for the successful registration of projects.
• Completion of clients’ pre-audit and audit checklists and questionnaires.
• Attend internal meetings and calls as requested by clients.  
• General communication with the Greek authorities for PharmaPath’s projects related to Greece.
• Support the preparation of price applications for PharmaPath’s projects related to Greece.
• Support the preparation, monitoring and revision of the RA budget.
• Monitor and update the BD milestone tracking system for assigned projects, ensuring timely milestone invoicing.
• Issue debit notes and liaise with the Accounting Department to facilitate accurate and timely invoicing of RA activities.
• Maintain and update internal databases.

Minimum and preferred qualifications:

• BSc Degree in Pharmacy, Biology, Chemistry, or another relevant field.
• At least 2 years of experience in Regulatory Affairs within a pharmaceutical company.
• Good knowledge of regulations, guidelines and procedures relating to registration of pharmaceutical products worldwide.
• Excellent English oral communication and scientific writing skills.
• PC literacy (Word, Excel, PowerPoint, etc).
• Strong organizational skills and problem-solving mentality.
• Ability to meet deadlines.
• Team working spirit.
• Oriented to focus on details.
• Effective communication both internally and externally.

Benefits:

• Competitive remuneration package, including benefits
• Ability to become part of one of the most dynamic and prospective teams in the Pharmaceutical industry in Greece
• Continuous opportunities in advancing personal and career goals