Global Regulatory Lead

1 settimana fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Job Summary

The Global Regulatory Lead plays a pivotal role in ensuring the Company's success by overseeing the Corporate R&D Pipeline. This involves providing regulatory guidance to the R&D Global Core Team and other non-R&D functions as needed.

Main Responsibilities
  • Collaborate with the Therapeutic Area head to contribute to company success
  • Develop and lead global/regional regulatory strategies for new and existing products, overseeing the Global Regulatory Team for assigned projects
  • Participate in OMNIS Development Core Teams
  • Lead according to established best practices
  • Manage and lead the preparation and review of regulatory applications, reports, and correspondence to ensure timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards
  • Act as single point of regulatory contact during inspections from health authorities when required
  • Manage pre-approval and post-approval activities as needed and in agreement with the Global Regulatory Team
  • Maintain relationships with health authorities, developing in-depth knowledge of relevant regulations and requirements
  • Provide support to IMDD, Affiliates, and Partners for prioritized issues and topics as needed
  • Maintain close relationships with R&D functions and Therapeutic areas, participating in and managing core team relationships or representing the Global Regulatory Team to TAM or XRC
Requirements
  • At least ten years of experience within Regulatory Affairs, with at least five years in the global context
  • University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
  • Written and spoken English
  • Knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance
  • Emotional and social intelligence, leadership and social influence, planning and organizational skills, and strategic thinking
What We Offer

You would join a dynamic, fast-growing, challenging, and friendly environment. Chiesi firmly believes that our people are our most valuable asset, which is why we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying particular attention to the quality of our working environment and 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 give our best. That is why we offer flexible working approaches, remote working, support in the relocation process, tax assistance services for foreign colleagues, and many other people-care services.

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