Global Regulatory Lead

1 mese fa

Parma, Emilia-Romagna, Italia Chiesi A tempo pieno
About Chiesi

Chiesi is a global pharmaceutical company with over 85 years of experience, operating in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.

Our R&D Team

Our R&D team represents a fundamental asset for the business, 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.

Job Description

We are seeking a Global Regulatory Lead to contribute to the Company's success by managing the Corporate R&D Pipeline (projects in R&D Development). The successful candidate will provide regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed.

Main Responsibilities
  1. Contributes to company success with collaboration from Therapeutic Area (TA) head
  2. Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects
  3. Participates in OMNIS Development Core Teams
  4. Leads according to established best practices
  5. Manages and leads the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards
  6. When required, act as single point of regulatory contact during inspections from health authorities
  7. Manages pre-approval and post approval activities, as needed and in agreement within the GRT
  8. Maintains relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements
  9. Provides as needed support to IMDD, Affiliates, and Partners for prioritized issues and topics
  10. Maintains close relationships with R&D functions and Therapeutic areas; i.e., participates in and manage core team relationships or represent GRT to TAM or XRC etc
Requirements

At least ten years of experience within Regulatory Affairs of which at least five in the global context. University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology. Knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance. Soft skills: Emotional and social intelligence, Leadership and social influence, Planning and organizational skills, Strategic thinking.

  • Global Regulatory Lead

    3 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    Global Regulatory LeadChiesi is seeking a highly skilled Global Regulatory Lead to contribute to the Company's success by managing the Corporate R&D Pipeline. The successful candidate will provide regulatory guidance to the R&D Global Core Team and other non-R&D functions, as needed.Main ResponsibilitiesCollaborate with the Therapeutic Area head to...

  • Global Regulatory Lead

    2 settimane fa

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

    Job Title: Global Regulatory LeadWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Group. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the success of our company by providing regulatory guidance and support to our R&D Global Core Team and other non-R&D functions.Main...

  • Global Regulatory Lead

    6 giorni fa

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

    Job SummaryThe Global Regulatory Lead is a critical role within the Chiesi Group, responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to the R&D Global Core Team.Main ResponsibilitiesContribute to company success through collaboration with the Therapeutic Area head.Develop and lead global/regional regulatory strategies for...

  • Global Regulatory Lead

    1 mese fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Group. As a key member of our Regulatory Affairs department, you will be responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to our R&D Global Core Team.Main ResponsibilitiesCollaborate with the Therapeutic Area head to contribute to...

  • Global Regulatory Lead

    3 settimane fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Group. As a key member of our Regulatory Affairs department, you will be responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to the R&D Global Core Team.Main ResponsibilitiesContribute to company success by collaborating with the...

  • Global Regulatory Lead

    2 settimane fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Group. This is a key role that will contribute to the company's success by managing the Corporate R&D Pipeline and providing regulatory guidance to the R&D Global Core Team.Main ResponsibilitiesCollaborate with the Therapeutic Area head to contribute to company...

  • Global Regulatory Lead

    3 settimane fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Group. As a key member of our Regulatory Affairs department, you will be responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to our R&D Global Core Team.Main ResponsibilitiesContribute to the company's success by collaborating with...

  • Global Regulatory Lead

    1 settimana fa

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

    Job SummaryThe 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 ResponsibilitiesCollaborate with the Therapeutic Area head to contribute to company successDevelop and lead...

  • Global Regulatory Lead

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About ChiesiChiesi is a global pharmaceutical company with a rich history of innovation and a commitment to improving people's quality of life. With over 85 years of experience, we operate in 31 countries and have a team of over 7,000 employees. Our mission is to act responsibly towards society and the environment, and we strive to achieve this through our...

  • Global Regulatory Affairs Specialist

    1 settimana fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

    Job SummaryWe are seeking a highly skilled Global Regulatory Lead to join our team at Chiesi Farmaceutici. As a key member of our Global Regulatory Affairs Team, you will be responsible for managing the Corporate RD Pipeline and providing regulatory guidance to the RD Global Core Team.Main Responsibilities:Contribute to company success by collaborating with...

  • Global Regulatory Lead

    4 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    Job DescriptionAt Chiesi, we are seeking a highly skilled Global Regulatory Lead to contribute to our company's success by managing the Corporate R&D Pipeline.Main ResponsibilitiesCollaborate with the Therapeutic Area head to contribute to company success.Develop and lead global/regional regulatory strategies for new and existing products as the leader...

  • Global Regulatory Affairs Senior Project Manager

    1 settimana fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Group. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and initiatives throughout their lifecycle.Main ResponsibilitiesDevelop and...

  • Global Regulatory Affairs Senior Project Manager

    6 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

    Job Title: Global Regulatory Affairs Senior Project ManagerAbout the Role:We are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Farmaceutici. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and...

  • Global Regulatory Affairs Senior Project Manager

    2 settimane fa

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

    Job Title: Global Regulatory Affairs Senior Project ManagerJob Summary:We are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team. As a key member of our Global Regulatory Affairs department, you will be responsible for ensuring the coordination and management of regulatory digital projects and initiatives throughout...

  • Global Regulatory Affairs Senior Project Manager

    6 giorni fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Group. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and initiatives throughout their lifecycle.Main ResponsibilitiesDevelop and...

  • Global Regulatory Affairs Project Manager

    4 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About UsChiesi is a leading international research-focused pharmaceutical and healthcare group with a rich history of over 85 years. Headquartered in Parma, Italy, the company operates in 31 countries with a strong presence of over 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment....

  • Global Regulatory Affairs Senior Project Manager

    2 settimane fa

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

    Job SummaryWe are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Group. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and initiatives throughout their lifecycle.Main ResponsibilitiesDevelop and...

  • Digital Regulatory Project Specialist

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    About the RoleWe are seeking a highly skilled and experienced Digital Regulatory Project Specialist to join our Global Regulatory Affairs team at Chiesi Farmaceutici S.P.A.Key ResponsibilitiesEnsure coordination and management of regulatory digital projects and initiatives during each phase (discovery, planning, execution, launch and maintenance).Ensure...

  • Digital Regulatory Project Senior Specialist

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About ChiesiChiesi is a global pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.Our R&D TeamOur R&D team represents a fundamental asset for the business, divided into...

  • Digital Regulatory Project Specialist

    3 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About ChiesiChiesi is a global pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.Our ValuesWe believe that our people are our most valuable asset, and we strive to...