Featured Opportunity
Head of Regulatory CMC
THE CLIENT:
Steeped in a broad pipeline of drug development, this publicly traded biopharmaceutical company is focused in multiple therapeutic areas, with current programs on both Fast Track and Orphan designations targeted toward genetic diseases. Their proprietary platform hovers between small and large molecules, and can be applied to multiple genetic diseases where gene silencing is bringing answers to many unsolved challenges in multiple therapeutic areas. The company prides themselves on hiring innovative, science-driven professionals to work in a nimble environment. Years of successful research and development has landed them at the forefront of the next frontier of successful drug approvals. With their own growing pipeline in a variety of indications, and currently being enlisted by several corporate partners that have come to them as the experts, they are well-funded not only for the near future but beyond. Their growth mode will be global and US with your input to help them succeed. With publicly traded stock, an entrepreneurial executive team with a track record of success they bring all the reasons to join a smaller organization with all the funding of a larger company!
THE ROLE:
Build the regulatory CMC function! As the leader of regulatory affairs CMC, you will be the regulatory CMC voice for strategic development, global submissions and agency interactions for their pipeline, as well as headlining all CMC interactions as the SME within the company, be part of the executive team, as well as work with Corporate partners that come to our client for their expertise. Working in the center of their R&D hub, you interact with leading scientists in development, chemistry and manufacturing, building relationships both internally and with external partners to ensure that the regulatory CMC function is providing global oversight, direction and management for all CMC regulatory activities and global expansion. Because of this proprietary platform the CMC role is front and center in all US and global approvals within the extensive drug pipeline. Their new state of the art API facility will look to you to assure the final finishing touches for approval. As the company grows so will your team that you create to provide CMC expertise to their continually expanding pipeline.
Steeped in a broad pipeline of drug development, this publicly traded biopharmaceutical company is focused in multiple therapeutic areas, with current programs on both Fast Track and Orphan designations targeted toward genetic diseases. Their proprietary platform hovers between small and large molecules, and can be applied to multiple genetic diseases where gene silencing is bringing answers to many unsolved challenges in multiple therapeutic areas. The company prides themselves on hiring innovative, science-driven professionals to work in a nimble environment. Years of successful research and development has landed them at the forefront of the next frontier of successful drug approvals. With their own growing pipeline in a variety of indications, and currently being enlisted by several corporate partners that have come to them as the experts, they are well-funded not only for the near future but beyond. Their growth mode will be global and US with your input to help them succeed. With publicly traded stock, an entrepreneurial executive team with a track record of success they bring all the reasons to join a smaller organization with all the funding of a larger company!
THE ROLE:
Build the regulatory CMC function! As the leader of regulatory affairs CMC, you will be the regulatory CMC voice for strategic development, global submissions and agency interactions for their pipeline, as well as headlining all CMC interactions as the SME within the company, be part of the executive team, as well as work with Corporate partners that come to our client for their expertise. Working in the center of their R&D hub, you interact with leading scientists in development, chemistry and manufacturing, building relationships both internally and with external partners to ensure that the regulatory CMC function is providing global oversight, direction and management for all CMC regulatory activities and global expansion. Because of this proprietary platform the CMC role is front and center in all US and global approvals within the extensive drug pipeline. Their new state of the art API facility will look to you to assure the final finishing touches for approval. As the company grows so will your team that you create to provide CMC expertise to their continually expanding pipeline.
To succeed in this role you need to:
Location: Madison, WI-commuting for a limited time possible
Madison is ranked #3 on this year’s Top 100 Best Places to Live list, because it excels in nearly every category across the board, including housing (which is 15% below the national average), economy and infrastructure. With 47 state parks, 13 state forests, 76 state wildlife areas, 84,000 river miles and 15,000 lakes, Wisconsin is an outdoor enthusiast's dream. Located 1 ½ hours from Milwaukee and a little over 2 hours from Chicago the “big city” metropolitan culture is a short distance away.
- Solid communication skills with the ability to be heard at the executive level, and understood at all levels within and outside of the organization
- Be an innovative and proactive problem solver with the desire to develop successful CMC strategies for previously challenging or unique submissions
- Have at least ten years of regulatory CMC experience with successful IND and NDA and/or BLA filings.
- An advanced scientific degree is preferred but a scientific Bachelor’s degree and strong regulatory CMC experience will be seriously considered
- Strong global regulatory CMC experience especially in the EU, Asia and Australia with a successful track record of FDA and global health authority interactions
- An entrepreneurial spirit that is excited to help this company to grow and is able to take on additional responsibilities and challenges as needed
- Previous success in the CMC development of innovative small molecules or biologics
Location: Madison, WI-commuting for a limited time possible
Madison is ranked #3 on this year’s Top 100 Best Places to Live list, because it excels in nearly every category across the board, including housing (which is 15% below the national average), economy and infrastructure. With 47 state parks, 13 state forests, 76 state wildlife areas, 84,000 river miles and 15,000 lakes, Wisconsin is an outdoor enthusiast's dream. Located 1 ½ hours from Milwaukee and a little over 2 hours from Chicago the “big city” metropolitan culture is a short distance away.
