Regulatory Affairs & Quality Assurance & Pharmacovigilance Associate

Location:

Metamorfosi Athens, GR, 14451

Description Overview

To handle local regulatory activities related with the submission, approval, launch of new products and maintenance of marketed products from the assigned brands for Greece and Cyprus.
To handle local quality activities to ensure the compliance with the required quality regulations.
To ensure that the Pharmacovigilance legislation is fulfil at local level

Assists in execution of regulatory activities for the project plan to assure new product meet submission, approval and commercial launch goals.
Maintains product labeling in compliance with laws and regulations; develop and approve label specifications in compliance with SOPs.
Reviews and approves claims and advertising material.
Maintains a high level of Regulatory Knowledge, regarding current or pending regulations.
Manages & controls the data housekeeping
Participates in partners’/internal audits
Supports the update of local SOPs in accordance with corporate SOPs and local requirements.
Promotes the system of deviations and CAPAs
Manages change controls
Ensures the compliance of quality requirements for products and services
Acts as deputy local contact person for pharmacovigilance with local authorities
Ensures that all Vigilance activities are conducted in accordance with local and corporate SOPs, Work Instructions, Good Vigilance Practice guidelines and regulatory requirements.

Degree in Pharmacy/Medicine/Dentistry/Biology/Chemistry or similar
Minimum 1 year experience in Regulatory Affairs and/or Quality Assurance and/or Pharmacovigilance
Experience in food supplements, medical devices, biocides or cosmetic products (desirable)
Fluent English, spoken and written
Communicative skills and Results Orientation.
Innovative and Analytical Thinker
Agile and ability to adapt to changes.
Decision making/ ability to negotiate
Team spirit.
Persistent in the search for results on shorter paths.
Organized and resolutive.