Job Description

Senior Manager Regulatory Affairs CMC – Lead Submissions for NBEs, UK, M4 Corridor

This is a permanent role leading submissions for NBEs in the EU and the rest of the world for an international pharmaceutical company based in the UK, South East of England.

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

Our client is an R&D driven, fast-moving, global Biotechnology Company with a pipeline of over 20 products in development. This organization over the years has pushed the boundaries of what is possible in order to make a real difference for patients’ lives. They have some exciting biologics coming in Ph2, Ph3 and a number of products in early development. The team is expanding, and this is an opportunity for a Snr Manager to join and lead as assigned some of the Regulatory Affairs CMC projects – authoring M2.3 and M3 of IMPDs/INDs and first MAAs/BLAs.

Major Accountabilities:

• Lead as assigned large molecule projects in development providing regional strategic and operational Regulatory CMC expertise.
• Write and review the CMC sections of global and regional submission documents, IMPDs, INDs, new MAAs and BLAs etc.
• Manage CMC aspects of HA questions.

What is there for you?

• Become part of a highly successful Biotechnology company that nurtures a team culture of mutual respect and support.
• Work on variety of projects in development, supporting drugs in Ph2 and Ph3.
• The locationis in the M4 Corridor and is easily commutable by train from London and Reading and is easily accessible by car with company car parking on premises. Flexible working hours are available and you will be able to work from home for a couple of days per week once you have settled down.

Experience needed:

• It is essential to have at least 5 years of Regulatory Affairs CMC experience authoring and reviewing of IMPDs for biological products as well as M3 for MAAs/BLAs.
• Experience of direct communication with the Health Authorities is required.

We look forward to hearing from you. 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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