Main duties & key responsibilities:
- Submission of new Marketing Authorization, variation and renewal applications for EU countries via MRP, DCP, CP, NP in eCTD format using relevant eCTD software.
- Preparation of Module 1 documentation (including Product Information) for all above mentioned applications and responses to Deficiency Letters (DLs).
- Liaise closely with EU and local Regulatory Authorities to facilitate approvals and address queries.
- Collaboration with internal and external parties and customers and coordination of all activities required for collection of all necessary information and documentation for compilation of Module 1 and responses to DLs.
- Attend internal meetings and calls with the Regulatory Authorities, suppliers, clients.
- Completion of clients’ pre-audit and audit checklists and questionnaires.
- 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.
- Keeping abreast of EU and local pharmaceutical legislation, guidelines, and practices.
Requirements:
- BSc Degree in Pharmacy, Biology, Chemistry, or another relevant field.
- At least 2 years of experience in Regulatory Affairs within a pharmaceutical company.
- Familiarity with EU regulatory frameworks and guidelines pertaining to the registration of pharmaceutical products.
- 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/12.
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.
