Global Regulatory Lead
2 settimane fa
Chiesi 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 research, development, and marketing of innovative drugs.
Job DescriptionWe are seeking a highly skilled and experienced Global Regulatory Lead to join our team. As a key member of our R&D department, you will be responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to our Global Core Team. Your expertise will be essential in ensuring compliance with internal and external regulatory standards, and you will play a critical role in shaping our regulatory strategies for new and existing products.
Key Responsibilities- Contribute to company success by collaborating with the Therapeutic Area head
- Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) 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 in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards
- Act as single point of regulatory contact during inspections from health authorities
- Manage pre-approval and post-approval activities, as needed and in agreement within the GRT
- Maintain relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements
- Provide as needed support to IMDD, Affiliates, and Partners for prioritized issues and topics
- Maintain close relationships with R&D functions and Therapeutic areas; i.e., participate in and manage core team relationships or represent GRT to TAM or XRC etc
We are looking for a highly experienced and skilled individual with at least 10 years of experience in Regulatory Affairs, with at least 5 years in the global context. You will need to have a university degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology, and excellent written and spoken English skills. You will also need to have knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance, as well as emotional and social intelligence, leadership and social influence, planning and organizational skills, and strategic thinking.
What We OfferWe offer a dynamic, fast-growing, challenging and friendly environment, with opportunities for continuous training, learning and development. We strive to 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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