Expiry Date: 01-11-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
“This is great opportunity for an experienced Regulatory CMC professional within Cell or Gene Therapy to join for one of the leaders in the industry in a global role offering a great package and excellent benefits!”
Remote options available - or multiple locations available on the East Coast.
My client is a biopharma focused on innovative medicines for patients with cancer and other serious diseases and is well positioned with a diverse portfolio of leading medicines. Their key therapeutic areas include Oncology, Hematology and Immunology and they have an enviable pipeline across multiple modalities.
Within the Cell Therapy space, they have already achieved successful registrations in the EU and US for several products and have a number of new MAA/BLA’s planned for 2022, 2023 and 2024 - this organisation is well positioned to unlock the full potential of Cell Therapy.
As the Director, Regulatory CMC Cell Therapy, you will lead small team that represents Global Regulatory CMC for either Cell Therapy pipeline products (P1 to P3 to MAA/BLA) or for a number of recently approved commercial product, overseeing the global role out to major territories and managing all major (EU/US) variations.
Your Regulatory CMC Cell Therapy team will provide strategic guidance and input related to current regulatory requirements interfacing with the Health Authorities for CMC submissions and CMC-related issues and your ability to identify, communicate and resolve complex issues will be key as you oversee the preparation and management of all key filings, ensuring thoroughness, accuracy and timeliness are all consistent within the Regulatory CMC Cell Therapy function.
The culture here can be described as collaborative, innovative and productive, but always with a strong eye on employee well-being and engagement, these are the fundamentals that keep this organisation growing, developing and succeeding in all areas! My client also openly recognizes the importance of balance and flexibility in the working environment, and they offer a wide variety of competitive benefits, services and programs that provide all employees with the resources to pursue their goals, both at work and in their personal lives.
The package and salary are high end, and you will also receive a very generous LTI plan, with good vesting periods that make the overall offer very strong. Of course, at this level, my client is willing to cover any loss of bonus (due to be received within the next 12 months), and any vesting shares due to you in the next 2 years.
To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore or my collegue, Christian on US 908 348 6714, or send a full CV to email@example.com and we would be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.
If this role isn’t quite for you but you are open to something new, we would welcome to discuss other roles we have open in the Cell and Gene therapy space.
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