Featured Opportunity
Executive Director Regulatory CMC
The Client
Come join this incredibly successful entrepreneurial team of 120 employees. The track record of this executive team includes building successful companies three different times, by developing and then launching a first in class drug, now they are ready to do it again! Be part of a group dedicated to delivering treatment for kidney disease which has not seen a breakthrough for 20 years, with their lead polymer product. Join their formula for success! This culmination of experience is derived by each employee not just being valued, but contributing creativity and dedication, and consequently creating value for patients benefiting from solving the “unsolvable”.
The Opportunity:
In this highly visible role, as the Head of CMC Regulatory Affairs, you will lead and launch CMC strategies leading to commercial development /launch in the US and Ex-US. A key function for the Senior Director Regulatory CMC will be taking the product through launch and overseeing sound CMC strategies for drug substance and drug product manufacturing for adherence to regulations, guidance’s, commitments and strategies for their lead polymer product.
Come join this incredibly successful entrepreneurial team of 120 employees. The track record of this executive team includes building successful companies three different times, by developing and then launching a first in class drug, now they are ready to do it again! Be part of a group dedicated to delivering treatment for kidney disease which has not seen a breakthrough for 20 years, with their lead polymer product. Join their formula for success! This culmination of experience is derived by each employee not just being valued, but contributing creativity and dedication, and consequently creating value for patients benefiting from solving the “unsolvable”.
The Opportunity:
In this highly visible role, as the Head of CMC Regulatory Affairs, you will lead and launch CMC strategies leading to commercial development /launch in the US and Ex-US. A key function for the Senior Director Regulatory CMC will be taking the product through launch and overseeing sound CMC strategies for drug substance and drug product manufacturing for adherence to regulations, guidance’s, commitments and strategies for their lead polymer product.
To succeed in this group you need to:
Location: San Francisco Bay Area
- Have the confidence, experience, and knowledge to oversee CMC strategies taking this product through final stages of approval and commercial launch.
- Bring prior achievement of a successful product launch with CMC oversight of all commercial manufacturing.
- Bring your communication skills to mentor and build your team.
- Have a proven track record representing Regulatory on project teams to outline submission requirements and define timelines for on-time delivery of high-quality regulatory CMC submissions.
- Lead the development, review and submission of CMC filings in the US and ex-US, including IND amendments, IMPDs and annual reports and CMC sections of NDA supplements and future marketing applications (e.g., MAA) for the Company’s lead polymer product.
Location: San Francisco Bay Area
