Pharmaceutical Oriented Services (PharOS) Ltd is a leading group of companies, established in 2002 within the pharmaceutical industry, dedicated in Product Development, Regulatory Affairs, Business Development and Out-Licensing across Europe and the globe.
Already one of the fastest growing generic companies in Europe, PharOS is currently seeking to recruit a Regulatory Affairs Project Manager (EU) with a minimum 3 years’ experience, based in company’s Headquarters in Athens.
Role and Responsibilities
The selected Candidate will be responsible for all activities associated with the submission of Marketing Authorisation Applications through the recognized regulatory European procedures (National, MRP, DCP, CP) and maintenance of the product registrations, such as variations and renewals, in accordance with the current EU legislation.
Experience & Qualification
Degree holder in Life sciences: Chemistry, Pharmacy, or related subjects.
Excellent Knowledge of EU Regulatory Framework and EU guidelines.
Experience in EU regulatory submissions, variations and renewals (minimum 3 years).
Experience in the compilation of Module 1 response documents throughout the European procedures.
Experience in publication of electronic regulatory submissions (eCTD) using eCTD manager software.
Experience using the variation classification guideline.
Excellent English oral communication and scientific writing skills.
Very good organizational and project management skills.
Oriented to focus on detail.
Communicate effectively both internally and externally.
PharOS Ltd Offers
Continuous training on all aspects of Regulatory Affairs