Regulatory Affairs Analyst

IQVIA LLC; Milano; Ibrido; EUR 33.000 - 49.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Regulatory Affairs Analyst in Italy for an initial maternity cover. You will manage regulatory lifecycle processes for medicinal products, prepare and coordinate documentation, and liaise with health authorities and clients to ensure timely submissions.

You will work in a hybrid setting with Milan as the focal area, collaborating with experienced colleagues to maintain compliance and deliver high-quality regulatory deliverables.

Competenze

• A bachelor’s or master’s degree in pharmacy, biology, biotechnology or another life-sciences discipline.
• Approximately two years of relevant Regulatory Affairs experience.
• Experience supporting operational regulatory activities for medicinal products.
• Prior work in a pharmaceutical company, CRO, consultancy or similar regulated environment.
• Understanding of the Italian regulatory environment and medicinal-product lifecycle activities.
• Experience preparing or coordinating regulatory documentation and submissions.
• Confidence communicating with clients, internal stakeholders and health authorities.

Mansioni

• Support the regulatory lifecycle management of medicinal products on the Italian market.
• Prepare, review and coordinate regulatory documentation and submissions.
• Support submissions and routine communications with Italian health authorities.
• Work with clients to understand requests, coordinate activities and meet deadlines.
• Assist with lifecycle maintenance, MA transfers, labeling, CMC activities and other procedures.
• Support activities connected with promotional materials and ongoing product maintenance.
• Track deliverables, timelines and priorities across multiple projects.
• Escalate risks or complex matters to senior colleagues when needed.
• Participate in meetings and communicate progress clearly.

Conoscenze

Regulatory lifecycle management

Client communications

Regulatory submissions

Planning and organisation

Formazione

Bachelor’s or Master’s degree in pharmacy, biology, biotechnology or life-sciences

Strumenti

Microsoft Office

Regulatory publishing tools

Descrizione del lavoro

Help keep essential medicines available to patients At IQVIA, our Regulatory Affairs teams help pharmaceutical clients navigate regulatory requirements and maintain medicinal products on the market.

We are looking for a Regulatory Affairs Analyst to join our team in Italy. This is an opportunity for an early-career regulatory professional to build broader experience across medicinal-product lifecycle activities, regulatory submissions and client support while working alongside experienced Regulatory Affairs colleagues. You will take ownership of routine operational activities, interact with clients and health authorities, and help ensure that regulatory deliverables are completed accurately and on time.

Contract: Fixed-term maternity cover

What you will do

• Support the regulatory lifecycle management of medicinal products on the Italian market.
• Prepare, review and coordinate regulatory documentation and submissions.
• Support submissions and routine communications with Italian health authorities.
• Work with clients to understand requests, coordinate activities and meet regulatory and contractual deadlines.
• Assist with lifecycle maintenance, marketing authorisation transfers, labelling, CMC activities and other regulatory procedures, depending on project requirements.
• Support activities connected with promotional materials and ongoing product maintenance.
• Track deliverables, timelines and priorities across several concurrent projects.
• Work closely with senior Regulatory Affairs colleagues, escalating risks or more complex matters when necessary.
• Participate in internal and client meetings and communicate progress clearly.
• Follow applicable procedures and quality standards while contributing ideas for practical process improvements.

What will help you succeed

• A bachelor’s or master’s degree in pharmacy, biology, biotechnology or another relevant life-sciences discipline.
• Approximately two years of relevant Regulatory Affairs experience.
• Practical experience supporting operational regulatory activities for medicinal products.
• Previous experience in a pharmaceutical company, CRO, consultancy or similar regulated environment.
• Understanding of the Italian regulatory environment and medicinal-product lifecycle activities.
• Experience preparing or coordinating regulatory documentation and submissions.
• Confidence communicating with clients, internal stakeholders and, ideally, health authorities.
• Strong planning and organisational skills, with the ability to prioritise activities against different client and authority deadlines.
• Good written and verbal communication skills.
• Strong attention to detail and the ability to follow established procedures consistently.
• Confidence using Microsoft Office and relevant regulatory systems or publishing tools.
• Fluent Italian and professional working proficiency in English.

Why join IQVIA?

You will join a collaborative Regulatory Affairs environment where you can develop your expertise through exposure to different clients, products and regulatory activities. You will be supported by experienced colleagues while having meaningful ownership of day-to-day deliverables and client interactions.

This role offers the opportunity to strengthen your knowledge of the Italian regulatory landscape, broaden your lifecycle‑management experience and contribute directly to keeping medicinal products compliant and available to patients.

Working arrangements

This is a hybrid position, combining remote working with attendance at the office for face-to-face collaboration. Candidates should therefore be based within reasonable travelling distance of Milan. The position is offered as fixed‑term maternity cover. The exact duration will be aligned with the employee’s effective period of absence, in accordance with applicable Italian requirements.

Join IQVIA and help deliver regulatory work that supports better healthcare outcomes.

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 33 000,00 € - 49 400,00 €.

The actual base pay offered may vary based on a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time).

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.