Grd Regulatory Affairs Specialist Eu&Int

Iqvia Italia; Lazio; 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, on behalf of Chiesi Farmaceutici, is seeking a Global Rare Disease Regulatory Affairs Specialist for EU and INT in Rome, Italy. The role supports submissions to regulatory authorities and lifecycle management for global rare disease products, collaborating with consultants, partners, and affiliates.

Requirements include 2–3 years in regulatory affairs at a multinational company, strong attention to detail, and advanced English.

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.

Mansioni

• Prepares, compiles, and maintains regulatory documents to support submissions to regional regulatory authorities within timelines.
• Plans, coordinates, and manages regulatory submissions to regional agencies throughout the lifecycle of Global Rare Disease products.
• Critically reviews regulatory submission documents and provides recommendations for improvement.
• Provides regulatory guidance to colleagues from other functions as needed.
• Prepares responses to questions from regulatory agencies within specified timeframes.
• Liaises with internal and external stakeholders to gather data for submissions.
• Uses data management systems to track regulatory information.

Conoscenze

English (advanced to fluency)

Time management

Attention to detail

Analytical thinking

Independent yet team player

Strumenti

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 this global, rare disease regulatory affairs specialist in EU and INT to join an exciting working environment in a dynamic and international atmosphere.

Global Rare Disease Regulatory Affairs Specialist EU&INT

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. xpavfwm Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 -) to IQVIA and to transfer those data to IQVIA's Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

Grd Regulatory Affairs Specialist Eu&Int • Rome, Italy