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 85 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 86 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.
The Regulatory Affairs Department of PharOS is seeking for a Regulatory Affairs Supervisor for Non-European submissions. Based in our offices in Athens, this is a permanent position reporting to Regulatory Affairs Manager, and will be accountable for the following role description:
Overall project management of Non-EU submissions and post-approval variations.
RA guidance and support to Project Managers for all ongoing / new submissions and post-approval variations.
Design of regulatory strategies for submissions in Non-EU countries based on local national requirements.
Setting up of internal RA database system and relevant SOPs.
Experience & Qualification:
The ideal candidate should have:
Degree holder in Life sciences: Chemistry, Pharmacy, or similar scientific disciplines.
Excellent knowledge of Non-EU general national requirements.
At least 2 years’ experience in Non-EU countries submissions.
A people-oriented approach as well as the ability to coach and motivate a team.
Excellent organizational, project management and problem-solving skills.
Excellent communicational skills, both internally and externally.
Excellent English oral and written communication skills.