Regulatory Affairs Assistant - Saluggia, Italy - ITA 2021-029

Job Title

Regulatory Affairs Assistant

Job Facts

Organizational Area
Corporate
Country / State
Italia
Place of work
Saluggia
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Regulatory Affairs Team Leader

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Temporary
Job ID
ITA 2021-029

Job Scope

Your Mission

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.

Main Responsibilities

Your Contributions
  • Maintaining compliance with relevant statutory, regulatory and industry best practices cGMP requirements, to achieve quality which enhances customer satisfaction with products and services
  • 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
  • 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
  • Supporting the participation to tenders
  • Supporting post-marketing vigilance activities

Qualifications Experience Personal Strengths Mobility

You
Education
Master’s Degree
Specialization
iology, Chemistry, Pharmacy, Engineering, or equivalent scientific degrees. Master’s degree in regulatory is a plus.
Experience

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 ).

Technical Competencies

Detailed knowledge of quality assurance and regulatory affairs within a regulated environment.

Skills
  • Personal characteristics: integrity, ethics, confidentiality, diplomacy, open-mind, sense of observation, perspicacious, resolute, self-confident
  • Time management
  • 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
Languages
Fluent spoken and written English. A second European language is a plus
Travel Availability
N/A
Relocation Availability
N/A
Training Required

Induction program once hired

Benefits

We Offer You

As for Company Policy