Expiry Date: 03-11-2022
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!”
Location: Remote (with offices on both the East and West 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, Haematology, and Immunology, and they have an enviable pipeline across multiple modalities.
Within the Cell Therapy space, they have already achieved successful registrations in the US and EU for several products and have a number of new 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 manage a small team that represents Global Regulatory CMC for either cell therapy pipeline products (P1 to P3) or for a recently approved commercial product, overseeing the for global role out to all the major territories and all major 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.
Please contact Theo Moore on US +1-908.348.6714 or via email at Theo@Advtalent.com and I would be happy to discuss the role further and give you more information.
If this role isn’t quite for you but you are open to something new, I would be happy to discuss other roles we have open.
To apply for this role, please contact me Theo Moore on US 908.348.6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!
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