Global Regulatory Affairs Manager
2 settimane fa
Date: 16 Dec 2024
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 31 countries with more than 7,000 employees. 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.
Chiesi Research & Development Our R&D team represents a fundamental asset for the business, focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, and pharmacovigilance.
Who we are looking for Purpose As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to contribute to the definition and execution of aligned US, EU, and/or global regulatory strategy.
Main Responsibilities Serve as a regional/local regulatory lead and point of contact with Health Authorities.Contribute to the development of global HA interaction strategy in collaboration with GRT.Develop Health Authority engagement and interaction plans for assigned products.Ensure accurate communication/interaction with relevant HAs for projects/products.Lead regulatory subteam to ensure NDA/BLA/MAA/Extensions/Variations filings meet project timelines.Align regulatory submission timelines with program level and company objectives.Contribute to content and reviews for regulated documents.Support operational and compliance activities for assigned deliverables.Support GMP, GCP, and GPV inspections from health authorities.Provide updates on project and submissions status at GRT meetings.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 Fluent in English.
Technical Skills Understanding of clinical development of drugs and/or novel biologics products.Understanding of LCM activities in major markets (e.g., EU/US/CN/JP/CA/AU).Ability to work in electronic document management systems, such as Veeva Vault.Demonstrated ability to handle multiple projects simultaneously.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. We invest in continuous training, learning, and development, promoting a quality working environment and collective well-being. We offer flexible working approaches, remote working, support in the relocation process, tax assistance for foreign colleagues, and many other people-care services.
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