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
- Competitive salary
- Healthcare package
- Continuous training on all aspects of Regulatory Affairs
- Challenging working environment