Regulatory Affairs

5 days ago

Budapest, Budapest, Hungary Carbyne Full time 60,000 - 120,000 per year
Carbyne has been retained by an international pharmaceutical partner seeking a Regulatory Affairs & Quality Assurance Head to join their entity in Budapest. As a member of the leadership team, this role will oversee the regulatory and quality teams and be responsible for managing pharmacovigilance and compliance activities within the organization.

Responsibilities:
Leading the team responsible for regulatory affairs, quality assurance, pharmacovigilance, and compliance tasks.Defining tasks for team members, tracking and supervising their progress, and fostering the continuous development of colleagues.Coordinating activities related to the licensing of company products with the national authorities.Preparing, submitting, and following up on regulatory documentation, and supplementing these materials at the request of authorities.Maintaining authorized products, submitting change notifications, and managing renewals or withdrawals of product authorizations.Supporting and supervising the work of the warehouse quality assurance and responsible person.Facilitating information sharing among logistics, quality assurance, and regulatory teams.Implementing the company's quality and environmental policies, setting and coordinating quality objectives, and promoting quality awareness.Overseeing corrective and preventive actions identified during external and internal audits or daily operations.Acting as the Local Compliance Officer, responsible for the effective implementation and continuous development of the Compliance Management System.Aligning the company's local compliance strategy with the regional/business unit compliance officer and monitoring its effective local execution.Requirements:
Degree in PharmacyProven leadership experience in the field of regulatoryExperience in quality is a big plusExperience in compliance and drug safety is a plusStrong analytical and communication skillsFluency in Hungarian and EnglishShould you be interested in the role please apply by sending your CV/should you have any question in regards the vacancy do not hesitate to leave a comment with your details.

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