Approval was made after an FDA inspection of the Harmans state-of-the-art, commercial-scale gene therapy manufacturing center in June 2020. Since Catalent’s partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy. “This is
Regulatory Publishing ManagerRegulatory ProfessionalsCambridgeshire, UK
- FULL TIME
CMC Director – Regulatory AffairsRegulatory ProfessionalsOxfordshire, UK
- FULL TIME
Site relationship partnerRegulatory ProfessionalsSurrey, UK
Regulatory Operations AssociateRegulatory ProfessionalsCambridgeshire, UK
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
Janssen receives approval from the FDA for its Spravato CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid
The European Commission (EC) has authorised the world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis. The authorisation for the subcutaneous (SC) formulation now applies to all previously approved indications for the intravenous (IV) formulation in adults including: ankylosing spondylitis (AS),