Expiry Date: 19-04-2023
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
We have a new opportunity graded Director of Regulatory CMC for an amazing organization transforming the lives of patients with serious diseases. Their aim is to develop transformative gene-based medicines based on CRISPR/Cas9 gene editing. They have an established portfolio of programs they are advancing across their core franchises in immuno-oncology, regenerative medicine and in-vivo and the management team has experience across all aspects of drug development and commercialization. They are now looking for energetic and talented people in Regulatory CMC who like challenges and want to make a difference.
This position will lead and manage regulatory CMC aspects of Cell and Gene Therapy biological products through all phases of development, including MAA/BLA and commercialization.
Reporting directly to the Head of Global Regulatory CMC, the Director, Regulatory Affairs CMC, will be responsible for developing, leading, and implementing global regulatory CMC strategies and the preparation and submission of high‑quality CMC sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs). You will provide CMC regulatory support and guidance for assigned projects and interface with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
Primary Responsibilities Include:
Desired Education and Skills:
A good time to Join:
It’s an exciting time to join my client as they continue to grow many of their core R&D functions. You will be joining a Global Regulatory Affairs group that is diversified, fun, friendly and collaborative, who are eager to take responsibility and make an impact. In return for your time, effort and expertise, you will receive a competitive salary, bonus and stock plan (including both RSU’s and Options) plus a benefits package that is generous and comprehensive around time off, healthcare (for you and your family), pension contributions, training support, maintaining a healthy lifestyle, work-life balance and much more.
The company HQ is based in Greater Boston, but the role can be fully remote or Hybrid.
To apply for this role, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or press the red “Apply for position” button or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.
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