Global Regulatory Affairs Quality & Process Specialist
Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for
Purpose
Responsible for ensuring adequate compliance and management of the GRA quality systems, processes, operational activities, and project coordination according to internal and external requirements.
Main Responsibilities
- Oversee GRA quality system documentation, maintenance, and compliance activities including:
Ensuring compliant a training plan is created, applied, and maintained throughout GRA
Manage GRA related deviations and correction action and preventive action plan (CAPA) as needed
Ensure GRA Manual, Standard Operative Procedure (SOP), and Working Instruction (WI) implementation and continuous improvement
- Establish and ensure cross-functional (GPV, GMD, and GCD) communication flows related to GRA activities.
- Oversee audit and inspection related activity, as needed based on GRA involvement, including ensuring coordination of pre-audit/inspection activities, participating in audits/inspections as needed and coordination of any post-audit/inspection CAPAs.
- Ensure GRA Key Performance Indicators (KPIs) are provided in a timely manner.
- Provide process related support for GRA projects including impact assessment of quality documents and process mapping as needed.
- Oversee Regulatory operational activities for the Therapeutic Areas (TAs) ensuring appropriate cross-functional support is provided to allow regulatory requirements and internal standards to be met to support the success of drug development programs.
Initiate cross-TA events within Regulatory Information Management System (RIMS).
- Manage and promote appropriate communication on GRA Quality and Process related activities/projects and HA regulations.
- Collaborate with Department Head on GRA Quality and Process budget related items, including the identification and appointment of alternatives (i.e. external consultancy) as needed.
Experience Required
A minimum of 5 years experience in Regulatory Affairs. In-depth knowledge of drug development and regulatory procedures.
Education
Life science degree
Languages
English fluent
Technical Skills
Knowledge of Regulatory Affairs procedures
Deep knowledge of the full drug development process, regulatory legislation and quality requirements.
Soft Skills
- Communication skills
- Digital mindset
- Planning and organizational skills
- Strategic thinking
- Team working
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
Screen readers cannot read the following searchable map.
Follow this link to reach our Job Search page to search for available jobs in a more accessible format.