Regulatory Affairs & Quality Assurance & Pharmacovigilance Associate

Location:

Metamorfosi Athens (14451) – Greece

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Science Jobs

Advertiser:

Perrigo

Job ID:

131448363

Posted On: 

24 December 2024

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

Scope of the Role
-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.

Experience Required
-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.

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