We are a highly effective organization, and through collaboration and commitment we can execute on our mission. Our operating principles define how we work together to achieve our goals:
My current role at Braeburn requires establishing and maintaining a quality system that complies with US FDA regulations for combination products. As a member of Braeburn’s CMC Team, I also collaborate with other functional groups in the organization to ensure that our product is safe, effective and consistent across batches. In my lead role in Quality, I work with contract manufacturing organizations (CMOs) to ensure GMP compliance and readiness of our partners for product launch.
As the Head of the Quality organization, I take very seriously how important it is for patients that the product Braeburn provides is consistently of the highest quality, meeting quality standards and exceeding customer’s expectations.
My greatest accomplishment has been building strong partnerships with the Quality Leadership at our CMO which has enabled me to help improve quality systems across our organizations.
Be patient with the pace of progress when dealing with regulatory agencies but remain enthusiastic that persistency will yield good results. Our work is important and people in the organization are committed to working together to solve this universal crisis.
I work in the Regulatory Affairs Department as a Regulatory Strategist with a focus on Nonclinical and Clinical Development. Regulatory Affairs professionals work closely with all departments to ensure that an asset is developed in a manner that meets the expectations of FDA, falls within the legal framework for drug development, and ensures access for patients who may benefit. We are always thinking of creative ways to ensure that we optimize access, and therefore benefit, to the patients while also meeting the regulatory expectations.
The regulatory team (and the company) had a huge win this year with regard to regulatory exclusivity. Being able to participate in the development of our strategy to support both the legal case for clinical exclusivity and the Citizen’s Petition for Orphan exclusivity was a very rewarding challenge.
Be an agile thinker. Indications falling within substance use disorder are complex and ever evolving. You must be able to think outside the box to support research and development activities in indications where there is not always a clear path to approval.