We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of over 250 customers in over 90 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.
Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.
We proudly employ more than 1,300 people from over 22 different nationalities across 9 locations. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision “to make a difference in people’s lives” through our everyday activities and our products.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Regulatory Labeling Associate for the Regulatory Affairs Department in our Marousi premises.
As a Regulatory Labeling Associate, the ideal candidate will perform the preparation and update of pharmaceutical products labeling texts and will be involved in the M1 dossier compilation for submission of new applications and lifecycle management operations (renewal, variations).
Requirements
More particularly:
What you will do:
- Maintain common labeling texts database up to date for regulatory submissions
- Create and update agent-specific labeling texts as per applicable legislation requirements
- Oversee common/agent-specific artworks preparation and update for submission purposes
- Prepare administrative documentation for regulatory submissions according to local Authorities guidelines within strict deadlines
- Interact with other departments and external stakeholders for certificates/samples requests as per the submission needs
- Coordinate regulatory documentation attestation activities
- Process Regulatory fees and invoices through SAP system
The ideal candidate should have:
- At least 2 years of relevant experience most preferable in the pharmaceutical area
- Bachelor’s Degree preferred or equivalent combination of education and experience
- Excellent communication in English language (writing & speaking)
Job-Specific Skills:
- Strong Computer literacy skills
- Multi-tasking
- Time management
- Ability to prioritize work and meet deadlines
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
