Senior Manager Regulatory Affairs CMC – lead submissions for NBEs, UK, M4 Corridor

Reference: Oli104872AR2

Expiry Date: 28-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

We are recruiting for a Snr Manager Regulatory Affairs CMC to lead projects in development for a leading biopharmaceutical company in the South East.

This is a permanent role for a Senior Manager Regulatory CMC, leading submissions for NBEs in the EU and the rest of the world.

Who is our client?

Our client is a fast-moving, international Biotechnology company, now expanding their Regulatory Affairs CMC team across the world. They are a global, R&D driven business that has over the years pushed the boundaries of what is possible in order to transform patients’ lives. This company invests heavily in cutting-edge scientific research, it supports is people and produces successful drugs that make real difference to people around the world.

What will your duties be?

- Lead as assigned large molecule projects in development providing regional strategic and operational Regulatory CMC expertise.
- Write and review global and regional Regulatory CMC submission documents, IMPDs, MAAs etc.
- Manage CMC aspects of Health Authority 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 location is easily commutable by train from London and Reading and is easily accessible via car with company car parking on premises.
- Flexible working hours are available and the role comes with competitive salary, bonus and lucrative stock plan.

What do you need to bring to the table?

- It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring dossiers for mAbs, vaccines, recombinant proteins, Cell & Gene Therapies or ATMP’s.
- Experience in successful authoring and compiling of IMPDs for biological products as well as MAA, Module 3 experience.
- Experience of direct communication with the Health Authorities.
- Demonstrated leadership, communication skills and emotional intelligence.

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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