Expiry Date: 31-05-2023
Category Regulatory Affairs
Job Type: Full Time
My team and I have been instructed by our Global Pharmaceutical client to find a Senior Manager for Regulatory CMC who is keen to experience the thrill of developing 1st MAAs, and enjoys working on phases 2 through 3 for medications targeting various indications. The company’s headquarters are in London, and both their financial reserve and market cap provide solid and dependable figures on which the company has built a solid foundation. Our client is over 50 years old, they have a strong and varied pipeline, great financial stability, offer excellent benefits and fully appreciate their teams having an excellent work-life balance and exciting career development opportunities.
We are looking for an energised and independent leader and team player who thinks outside the box but likes to collaborate and is creative in finding solutions. You will be working side by side with committed professionals on all levels, who really wish to make a difference, who are aligned with the company goals to deliver on their promise to put patients first.
You will be the RA CMC Regulatory lead for Line extensions, Lifecycle management, and MAA Module 3 preparation with the full support from a strategic and focused Head of Regulatory CMC with many MAA submissions under her belt. So, ideally you will be seasoned in extension applications, IMPD documentation for CTAs, first MAAs and/or PIPs, as well as experienced in the preparation of documentation for both minor and major CMC post-approval variations. If your background has been in small molecule dosage forms but you are familiar with biological products, then you would be a perfect match for the company’s expanding pipeline and their key indications.
This mid-sized organization is the right career move for you if you can appreciate both the convenience a home office brings and the irreplaceable synergy of an office full of creative thinkers, in role where you will be encouraged to take more leadership/project responsibility and grow your experience and expertise!
If you are interested in applying for this role, my team and I would be happy to present you with more information and guide you through the process! The role comes with a substantial package comprised of a strong base salary, a very decent bonus, and an exciting company benefits.
To apply for this role, please contact me, Ivan Nash on +44 207 801 3388 or send a full CV to Ivan.Nash@AdvTalent.com and I will reply by return. Our team will support you throughout the interview and on-boarding experience.
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