GRA EU Regulatory Affairs Specialist
Anywhere in Europe, FR
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). 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, 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 for
Purpose
The GRA EU RA Specialist ensures the execution of regulatory plans in the Region EU for the assigned portfolio.
Main Responsibilities
- Support the preparation and submission of MA applications, MA transfers, renewals, variations and management of relevant follow-up;
- 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.
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