GRD Regulatory Affairs Specialist EU&INT

IQVIA Italia; Parma; In loco; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

Private health insurance

Pension fund

5% bonus/MBO

Descrizione del lavoro

Chiesi Farmaceutici, in collaboration with IQVIA, seeks a Global Rare Disease Regulatory Affairs Specialist EU/INT to join a dynamic, international team.

Under supervision, you will prepare regulatory documents for submissions, coordinate lifecycle management, and liaise with partners to ensure timely responses.

The role offers a competitive salary, 5% bonus, private health insurance and a defined career path within a multinational environment.

Competenze

• 2-3 years experience in regulatory affairs in EU or INT.
• Experience in lifecycle management of regulatory filing.
• Ability to prepare high-quality submissions under supervision.
• Strong attention to detail and document quality.
• Well-developed written and oral communication skills.
• Strong time management and ability to manage complex tasks.
• Ability to work independently or in a team.
• English level from advanced to fluency.

Mansioni

• Prepare and maintain regulatory documents for submissions to regional authorities within timelines.
• Plan, coordinate and manage regulatory submissions to regional agencies across product lifecycles.
• Review submission documents and provide recommendations for improvement.
• Provide regulatory guidance to colleagues from other functions.
• Prepare responses to questions from regulatory agencies within timeframes.
• Liaise with internal and external stakeholders to obtain data for submissions.
• Use data management systems to track regulatory information.

Conoscenze

Regulatory affairs experience

Attention to detail

Time management

Written and oral communication

Team player

Independent work

English proficiency

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;

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);

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).