It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.
The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, the Head of Regulatory Affairs position will be part of the new Ironwood. The role will remain as described here.
Functional area: Regulatory Affairs
Over the past several years Ironwood has experienced sustained, rapid growth, which is projected to continue in the foreseeable future. The Regulatory leader has played a critical role in Ironwood’s success. As the company transitions to a focused development and commercialization company with a strong pipeline, it has been deemed necessary to recruit a seasoned Head of Regulatory Affairs. This person will play an active, critical role in developing and executing the overall global regulatory affairs strategy as the company continues to advance its pipeline and commercialize new and novel drugs. Such an individual is the object of this search.
The Head of Regulatory Affairs will report to Head of Global Development/ Chief Development Officer and will lead Ironwood’s regulatory department to support the development, registration, and life?cycle management of the company’s products. Ironwood’s regulatory team is responsible for devising and implementing regulatory strategies, preparing and submitting regulatory documents, providing regulatory advice, and reviewing and approving external facing communications. The Head of Regulatory Affairs will ensure that programs are resourced with appropriate regulatory expertise to successfully implement regulatory strategies and business objectives. S/he will also lead development and implementation of department policies as well as maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. S/he will continue to evolve the regulatory organization while providing oversight and mentoring to an established regulatory team. This team works well together with external global partners and other internal departments; therefore, we are looking for a like?minded regulatory scientist who values a collegial work environment and evidence-based strategies. The Head of Regulatory Affairs will not only play a major role in ensuring collaboration and strong relationships both internally with various departments, but also externally with regulatory agencies, business partners and vendors.