GRD Regulatory Affairs Specialist EU&INT

IQVIA Italia; Emilia-Romagna; In loco; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

Private health insurance

Pension fund

Flexible benefits

Descrizione del lavoro

IQVIA Italia, on behalf of Chiesi Farmaceutici, seeks a Global Rare Disease Regulatory Affairs Specialist for EU and international submissions in a multinational context. The role focuses on preparing regulatory documents, coordinating regional filings, and ensuring quality submissions within timelines.

The ideal candidate has 2–3 years in EU/INT regulatory affairs, strong attention to detail, and fluent English, with the ability to work independently in a dynamic, international team based in

Competenze

• 2-3 years experience in regulatory affairs in EU or INT or both at corporate level in a multinational company.
• Experience and knowledge in the life cycle management of regulatory filing.
• Ability to work under supervision in the preparation of high-quality submissions and submission documents.
• Strong attention to details and quality of documents and processes.
• Well-developed written and oral communication and listening skills.
• Well-developed time management skills and demonstrated ability to manage complex assignments.
• Well-developed analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• English level from advanced to fluency.

Mansioni

• Under guidance of the manager, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline.
• Plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
• Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., and provide recommendations for improvement.
• Provides regulatory guidance to colleagues from other functional areas when requested.
• Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified.
• Liaises with internal and external customers to request and obtain data relevant to submissions.
• Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.

Conoscenze

Regulatory submissions

EU Regulatory Affairs

Lifecycle management

Attention to detail

Written and verbal communication

Time management

Analytical skills

Independent work

English fluency

IT skills

Descrizione del lavoro

On behalf of our Client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Global Rare Disease Regulatory Affairs Specialist EU&INT to join an exciting working environment in a dynamic and international atmosphere.

Main regulatory responsibilities:

• Under guidance of the manager, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline;
• In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products;
• Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission;
• Upon request of the manager, provides regulatory guidance to colleagues from other functional areas;
• Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified;
• Liaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions;
• Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.

Requirements:

• 2-3 years experience in regulatory affairs in EU or INT or both at corporate level in a multinational company;
• Experience and knowledge in the life cycle management of regulatory filing;
• Ability to work under supervision in the preparation of high-quality submissions and submission documents;
• Strong attention to details and quality of documents and processes;
• Well-developed written and oral communication and listening skills;
• Well-developed time management skills and demonstrated ability to manage complex assignments;
• Well-developed analytical and problem-solving skills;
• Ability to work independently and as part of a team;
• English level from advanced to fluency;
• Good IT skills level.

Type of contract:

• National Collective Labour Agreement: Chemical and Pharmaceutical Industry;
• Contract Type: Staff Leasing with IQVIA;
• Salary Range or Gross Annual Salary: from 40.500€ to 50.600€ RAL.

The role also includes:

• variable bonus/MBO: 5%;
• private health insurance (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector);
• pension fund (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector);
• flexible benefits/corporate welfare.

The salary range is defined based on experience, skills, and internal equity criteria. Career progression and compensation review are based on transparent, objective criteria. We are committed to fair and equal pay practices, in line with applicable pay transparency regulations (EU Directive 2023/970).

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. The research is urgent and is intended for candidates of both sexes (L.903/77).