Regulatory Affairs Project Manager

Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.

At PharOS, we have a high skilled workforce of more than 400 professionals. Biologists, Chemists, Pharmacists, scientists all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients to more than 98 countries.

Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe. For PharOS our customers, are our partners Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.

PharOS is seeking for a Regulatory Affairs Project Manager within the RA department as follows:

Role description

• Handling of Marketing authorization applications, variations, and renewal procedures for EU countries via MRP, DCP, CP, NP
• Preparation of Module 1 documentation for initial submissions and responses to deficiencies letters
• Preparation of product information
• Communication with authorities and respective parties for the successful registration of the projects
• Compilation of eCTD dossiers (using respective eCTD software)
• Monitoring of Greek and EU legislation, guidelines, and practices
• Communication with clients for the preparation of the documentation needed for submission and approval of Marketing Authorization Applications, variation and renewal procedures in RoW territories
• Support, planning and coordination of all activities needed for the RoW registration process of pharmaceutical products developed by PharOS according to local requirements

Experience & Qualification

• Degree holder in Life sciences: Pharmacy, Biology, Chemistry or similar scientific disciplines
• At least three (3) years of experience in regulatory procedures
• 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, ppt etc)
• Excellent organizational, project management and problem-solving skills
• Team working spirit
• Oriented to focus on detail
• Ability to deliver under specific deadlines
• Communicate effectively both internally and externally

PharOS Ltd Offers

• Competitive remuneration package (including bonus based on performance)
• Private Health & Medical Insurance including a 24/7 support Line
• Hybrid work-from-home model (3 days office based and 2 days home based)
• Daily free transportation from/to the Company's HQs to nearby public means of transportation
• Canteen with discounted prices and daily cooked meals
• Continuous training
• Friendly and challenging working environment

PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.

Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.