Regulatory Affairs Officer

IQVIA LLC; Monza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading global provider in clinical research services seeks a Regulatory Affairs Officer to prepare and review regulatory submissions, support clinical trial activities, and manage project timelines. The ideal candidate has a degree in Lifesciences and a minimum of two years of relevant experience, with strong communication and organizational skills.

Competenze

• Bachelor's or Master's in Lifescience required.
• At least 2 years of relevant experience.
• Strong communication and organization skills.

Mansioni

• Prepares and reviews regulatory submissions documents.
• Tracks project timelines and implements client requests.
• Participates in project teams and communicates with clients.

Conoscenze

Interpersonal communication

Organization skills

Self-motivation

Formazione

Bachelor's Degree in Lifescience

Master's Degree in Lifescience

Strumenti

Microsoft Office

Descrizione del lavoro

Regulatory Affairs Officer page is loaded

Regulatory Affairs Officer Apply locations Milan, Italy time type Full time posted on Posted 2 Days Ago time left to apply End Date : July 15, 2025 (4 days left to apply) job requisition id R1455565

Job Overview

Under general supervision, Prepares and / or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and / or external clients. Provides regulatory support for assigned projects.

Essential Functions

• Acts as a Regulatory Team Member on small, straightforward regulatory projects and / or gets involved in a small single service project, under the guidance of senior staff;
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
• Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls / Lifecycle Maintenance / Marketing Authorization Transfers / Labeling / Publishing as applicable;
• Prepares and / or reviews regulatory documentation in area of expertise, as appropriate;
• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
• Understands the Scope of Work, deliverables for any given project;
• May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
• May prepare and deliver trainings, as appropriate;
• Performs other tasks or assignments, as delegated by Regulatory management;
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

Qualifications

• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• At least 2 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and / or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Applicable certifications and licenses as required by country, state, and / or other regulatory bodies

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

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