CMC Regulatory Associate / SpecialistDate Posted: 06/09/2020
Application Close: 30/09/2020
Location: Arcinova - Alnwick
An exciting opportunity has arisen for a Scientist to join the Client Services Regulatory team. The successful applicant will have a good understanding of the drug development process and CMC activities within the ARCINOVA organisation. .
An exciting opportunity has arisen for a Scientist to join the Client Services Regulatory team. The successful applicant will have a good understanding of the drug development process and CMC activities within the ARCINOVA organisation.
The role will include:
- The coordination, production and review of early clinical phase CMC regulatory documentation, including that for radiolabelled submissions, prior to their submission to global regulatory agencies
- Working as part of cross-functional project teams with colleagues from DS/IL/QC and DP
- Acting as a point of contact for assigned studies
- 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 drug substance and drug product related CMC regulatory advice to colleagues and ARCINOVA Clients.
Required skills and experience:
- A minimum of a Degree in Chemistry/Analytical/Pharmaceutical Sciences and over 2 years’ experience of working in a CMC (Chemistry, Manufacturing and Control) environment is essential
- Excellent interpersonal and communication skills
- Ability to work independently and produce high-quality work with attention to detail
- A flexible approach to new work challenges and the ability to work to demanding timelines
- Previous experience of in preparation of regulatory documentation would be advantageous but not essential.
To apply please email your letter of application, CV and any relevant supporting documents to Jodie Staton.
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