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CMC Regulatory Specialists and Project Managers
The successful applicants will have experience of preparing CMC regulatory documentation for early clinical phases and familiarity with the drug development process.
The role will include:
- The coordination, production and review of early clinical phase CMC regulatory documentation prior to their submission to global regulatory agencies
- Acting as project manager and client point of contact, for assigned CMC projects
- Participating in discussions with potential clients and assisting in the preparation of regulatory documentation related work proposals
- Preparing and assisting in the preparation of selected CMC documentation types such as release monographs
- Providing API and drug product related CMC regulatory advice to colleagues and ARCINOVA clients
- Working flexibly to meet ARCINOVA business needs
Excellent written/oral communication and interpersonal skills together with a good knowledge of early phase, CMC regulatory requirements are essential.
SMi Highly Potent Active Pharmaceutical IngredientsThe SMi Highly Potent Active Pharmaceutical Ingredients Conference will be attended by Mark Anstiss, Scale-up Chemist.
SMi Highly Potent Active Pharmaceutical IngredientsDates: 21st - 22nd MayLocation: Birmingham, UK
66th Annual ASMS ConferenceThe 66th ASMS Conference on Mass Spectrometry and Allied Topics Conference will be attended by Michael Blackburn, Method Development Scientist (Physiochemical). Michael will also be presenting during the conference, at the Proteins & Peptides Waters Users Meeting, with a presentation entitled; A Powerful Hybrid IA-LC-MS/MS Method Quantification of Insulin Analogues and
66th Annual ASMS ConferenceDates: 3rd - 7th JuneLocation: San Diego, US
2018 BIO International ConventionThe 2018 BIO International Convention will be attended by Mark Chadwick, Head of Business Development.
2018 BIO International ConventionDates: 4th - 7th JuneLocation: Boston, USA