Global Regulatory Affairs Manager
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
As core member of the GRT and strategic partner of the GRL, leverages their regulatory expertise to contribute to the definition and drive the execution of aligned US, EU and/or global regulatory strategy working flexibly within and across regions to ensure the delivery of business objectives.
Supports development and/or execution of Global Regulatory Strategy to support the TPP
Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).
Main Responsibilities
- May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities.
- May contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT.
- Accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products incl. authoring, leading and moderating preparation meetings.
- Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit.
- Leads, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate.
- Ensures that regulatory submission timelines are aligned with program level and company objectives.
- Contributes to content and reviews for regulated documents
- Supports operational and compliance activities for assigned deliverables, HA contact report (EU & US).
- Supports GMP, GCP, and GPV inspections from health authorities.
- Accountable to provide updates on project and submissions status at GRT meetings.
- Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.
Experience Required
At least 5-7 years’ experience in Regulatory Affairs
Education
Master's degree
Languages
English fluent
Technical Skills
- Emerging understanding of clinical development of drugs and/or novel biologics products
- Understanding of LCM activities (strategy and executions in major markets eg. EU/US/CN/JP/CA/AU)
- Ability to work in electronic document management systems, such as Veeva Vault
- Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.
- Strong sensitivity for a multicultural/multinational environment
- Data readiness & competitive intelligence
Soft Skills
- Team working
- Stress management
- Time management
- Planning and organizational skills
- Strategic thinking
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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