Kind of contract
Support execution of the Regulatory Master Plan for the assigned area in respect to the Regulatory strategy of the Company. Maintain compliance with relevant statutory requirements while ensuring regulatory support to the European DiaSorin Sites.
Maintaining compliance with relevant statutory, regulatory and industry best practices cGMP requirements, to achieve and continuously improve quality which enhances and maximizes customer satisfaction with products and services provided by the Company
Supporting execution of the Regulatory Master Plan, cooperating actively with the other Regulatory teams and external stakeholders
Working closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle
Collaborating in keeping company informed of regulatory requirements, with a specific focus on international markets
Reviewing/Approving Change Requests and assess regulatory impact of product changes and manage/ supervise related submissions
Preparing/Supervising registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in international markets
Reviewing/Approving proposed labeling for compliance with applicable regulations
Ensuring compliance with applicable EU and international law/standards
Supporting the participation to tenders
Supporting post-marketing vigilance activities
Qualifications Experience Personal Strengths Mobility
1/2 years experience in the same or similar role within international context in the health care and sciences industry (preferably diagnostic, medical devices or pharmaceutical industry ).
Detailed knowledge of quality assurance and regulatory affairs within a regulated environment.
Personal characteristics: integrity, ethics, confidentiality, diplomacy, open-mind, sense of observation, perspicacious, resolute, self-confident
Good communication skills
Team work and collaboration with other individuals and functions
Ability to manage relations with internal and external stakeholders
Attention to details
Sense of urgencies
Induction Program Once Hired
As per Company Policy