Regulatory CMC Senior Manager**Work on a 1st filing and first round of line extensions**Hybrid, London

Reference: JPC547

Expiry Date: 31-05-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Greater London
United Kingdom

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Job Description

Our team has just begun recruiting for a mid-sized pharmaceutical company in need of a dynamic Senior Manager of CMC based in the greater London area. The organization is very reputable and known for putting patients first, being innovative, and thinking differently. They have an exciting and expanding range of approved meds and solid data on their projects in the pipeline.


In this role you will be developing 1st MAAs, working on phases 2 through 3 for medications targeting various indications. You will support the company’s CMC-related regulatory activities for assigned products at different stages of their life cycle.


This exciting and rewarding opportunity is the right choice for you if you wish to gain a wider experience of different submission types and insight in other areas of regulatory affairs. If you are eager to work closely with your CMC technical and manufacturing teams and really make a name for yourself, this is your chance to develop your knowledge in all aspects of CMC regulatory.


- Do you possess robust proven experience of small molecule sterile and oral products?

- Have you overseen extension applications for new strengths?

- Do you have a good strategic and technical mindset?

- Are you willing to contribute to build a stronger EU regulatory affairs function at a new company that welcomes all newcomers passionate about the changes they make in the lives of patients?


Then this is the role for you, and I would be happy to present you with more information and guide you through the process!


The company is very financially stable and has decades of proven success on which their foundations lay. They offer a solid salary that also includes bonus and car allowance. The role itself is hybrid and will allow you to both work from home and spend time face-to-face with your colleagues on site.


To Apply!


To apply for this role, please contact me, Ivan Nash on +44 207 801 3388 or send a full CV to and I will reply by return. Our team will support you throughout the interview and on-boarding experience.

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