Regulatory Affairs & Quality Assurance & Pharmacovigilance Associate
Job Description
Industry: Pharmaceutical Manufacturing, Research Services, and Manufacturing
Seniority for this role: Entry level
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. Show more Show less
