The role should be based in the UK
Following our exciting collaborations with both Merck KGaA, Darmstadt, Germany, and Novartis, and with an expanding small molecule drug discovery portfolio Artios Pharma is recruiting for an experienced Director of Regulatory Affairs. This is an excellent opportunity to join a world class research team in a dynamic, small Biotech company based south of Cambridge, UK. Artios is focused on identifying and developing cancer treatments by exploiting novel targets within the DNA damage response (DDR), a scientific area of high expectation following the success of PARP inhibitors in the clinic. The company is actively working on an exciting portfolio of unique DNA repair projects.
Artios has 2 molecules in clinical development, our small-molecule ATR inhibitor and small-molecule Polθ inhibitor.
Outline of the role
You will join a growing research team within this innovative and expanding company. Your primary responsibilities to lead all interactions with regulatory authorities and in doing so will liaise closely with the Clinical Development, CMC, Quality, Translational and Biology teams. You will drive the creation, implementation, and execution of all regulatory matters. You will also assist in developing the regulatory strategy for Artios product candidates and will lead the responses to global regulatory authorities when it is necessary to do so.
• 10 to 15 years of experience in regulatory affairs
• BSc or equivalent
• Oncology experience
• A PhD, Pharm D or equivalent
• A strong technical understanding of regulatory affairs in a biotech or pharmaceutical industry setting
• Recent experience in the development of products for oncology indications
• Experience leading regulatory submissions such as CTAs, INDs and obtaining Scientific Advice.
• Excellent understanding of and ideally experience in obtaining marketing authorisations for oncology products
• Experience working with global regulatory agencies and specifically the European Medicines Agency and the Food and Drug Administration.
• Awareness of developments in the regulatory landscape including ICH and relevant guidelines and legislation.
Key Skills and Abilities
• Excellent communication, influencing and interpersonal skills
• Excellent organisation and time management skills, with the ability to prioritise and multi-task
• MS Word, Excel, PowerPoint
• Flexible approach to change
• Ability to work independently in an organised and methodical fashion
• High level of IT literacy
• Excellent presentation skills
This is a permanent position, offering an attractive salary & benefits package. If you have the right background, then please apply by sending your CV with a covering letter to firstname.lastname@example.org quoting Ref 4234.
The closing date is Tuesday 9th November.
In order to comply with UK Employment Law, all applicants must have the Right to Work in the UK or if from the EU, subject to receiving a relevant Skilled Worker Visa to work in the UK.
No agencies, thank you