Main duties & key 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.
Requirements:
- 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.
To apply, kindly submit your CV at HR@PharmaPath.eu referencing the code RAS/11.
Based on your consent all received applications will be stored in our database for maximum 6 months and all data will be treated with strict confidentiality commensurate to data protection regulation.
