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Gra Eu Regulatory Affairs Junior Specialist
1 settimana fa
Date: 30-Mar-2023
Department:
Global Regulatory Affairs
Team:
R&D, Pharmacovigilance & Regulatory Affairs
Job Type:
Direct Employee
Contract Type:
Permanent
Location:
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 30 countries with more than 6,000 employees (Chiesi Group).
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 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.
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, chemical manufacturing and controls, 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) and Toronto (Canada).
Who we are looking forPurpose
The GRA EU RA Specialist ensures the execution of regulatory plans in the Region EU for the assigned portfolio.
Main Responsibilities
Support the Business continuity and GMD strategic plans;
Support the R&D projects cross-functional teams;
Timely inform and coordinate the EU affiliates, other GRA units (operations and CMC), corporate functions (GMD, GPV, GCD, GMA and global MKTG) and external stakeholders (licensors, partners and licensees) for the achievement of the assigned task
Compile and maintain the regulatory databases
Experience Required
3-5 years of experience in Regulatory Affairs in an international pharmaceutical company
Education
Scientific Degree
Languages
English fluent
Technical Skills
Good knowledge of the European pharmaceutical legislation, relevant guidelines, procedures and requirements
Good knowledge of the basic Office programs
Ability to prepare PowerPoint presentations
Ability to search and retrieve information from the worldwide web
Soft Skills
Analytical skills
Communication skills
Digital mindset
Problem solving
Time management
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.
DISCOVER ALL OUR JOB OPPORTUNITIES
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