Novartis unit Sandoz has gained approval from the FDA for its filgrastim biosimilar, Ziextenzo. Ziextenzo is a long-acting form of filgrastim approved to reduce the incidence of infection in cancer patients that are receiving chemotherapy. The Infections tend to be manifested by low white blood cell count and fever in patients with non-myeloid malignancies on
Product Stewardship SpecialistRegulatory ProfessionalsUK, Scotland
Regulatory Affairs Assistant ManagerRegulatory ProfessionalsHertfordshire, UK
Associate Director, Medical WritingRegulatory ProfessionalsHertfordshire, UK
- FULL TIME
Senior Regulatory ManagerRegulatory ProfessionalsUSA, Pennsylvania
- FULL TIME
Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
Our integrated regulatory affairs recruitment team is there to support partner organisations of all sizes. Ranging for one regulatory consultant, to deliver a specialist project, to outsourcing functional regulatory teams of over 100+, Regulatory Professionals are able to offer global support partnered with expert local knowledge. Our capabilities also offer contract and permanent regulatory staffing services to allow a 360 degree service range for all aspects of regulatory delivery.
Our regulatory recruitment teams approach is tailored to meet the needs of our partners requirements allowing you to shift internal R&D focus to more strategic activities to improve lifecycle performance.
The benefits of Regulatory Professionals integrated teams are measured not just in the savings that could result in multi-mullion dollar cost reductions, but equally in understanding that delays in any part of the regulatory cycle affect the ability to give patients access to transformational products.
Our integrated teams support your product portfolio by giving you flexibility of resource at the peaks and troughs of the product life cycle, while ensuring you maintain control of strategic regulatory departments. This is supported by consistent, measurable and tracked metrics to maximise accountability.
To find out more about each of the regulatory areas we specialise in, take a look at the following regulatory recruitment services:
Our experienced specialist recruitment consultants are available to speak to you confidentially about our outsourcing regulatory affairs services. To find out more information or to discuss any of our regulatory vacancies, please call our specialist regulatory affairs recruitment team.
Contact us today to find out how we can progress your career to the next level
The European Commission (EC) has approved Merck and Pfizer’s Bavencio (avelumab), in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Both companies say that the approval made as a result of positive interim results from the Phase III JAVELIN Renal 101 study, which found that the combination
The FDA has cleared Bayer and Johnson & Johnson’s anticoagulant Xarelto for use in hospitalised, acutely ill medical patients at risk of serious blood clots. The approval came as a result of data from the MAGELLAN and MARINER trials of Xarelto (rivaroxaban), which showed that the drug could be safely used to prevent venous thromboembolism