Position description: The Sr. Director of Global Regulatory Affairs Strategy is responsible for developing global regulatory strategy for products within scope in development and through life cycle management. Strategies should be based on relevant guidance commercial needs and company objectives.
Develop and lead Global Regulatory strategy for Development team(s) with regulatory team members, creating a global regulatory plan for products in scope, based upon relevant guidance commercial needs and company objectives
Guide team in developing strategic direction for assets/ indications and provide leadership for regulatory interactions.
Anticipate and interpret key trends and changes in the global and US regulatory environment and provide strategic guidance regarding development plan(s)
Foster trust-based relationships with global Health Authorities
Build and maintain strong working relationships with key internal and external stakeholders, including Global Regulatory leadership team, Commercial, Medical Affairs, Advertising & Promotion, Global development and other functions key to the success of product development
Interact routinely and develop strong collaborative relationships with colleagues throughout Global Regularity Affairs, including strategists, CMC, labeling, and Operations
Build and maintain strong working relationships with key external stakeholders, including alliance partners, agencies, and consultants
Provide leadership and strategic direction with regulatory colleagues in development partnership agreements
Oversee or provide due diligence support, as needed
Oversee strategy, preparation and submission of global regulatory submissions
Direct and mentor regulatory staff
PhD, MD or PharmD, or MS with commensurate experience
Understanding of global and US policy, laws, regulatory and guidance/ guidelines
Demonstrated competency in drug development process and understanding of scientific content and complexities. Preferred TAs of interest include gastroenterology, cardiovascular, metabolic and neuroscience.
Direct experience in leading the development of global and US regulatory strategies and leading teams through HA interactions and to drug/ biologics approvals
Experience leading professional regulatory team members
Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals, including advisory committee meeting(s).
Must be able to work successfully within a team/partnership environment with a high level of professionalism
Global regulatory experience - familiarity with regulations in other countries (e.g., EU, Canada, Australia, Japan) is desired
Internal Number: 1427
About Ironwood Pharmaceuticals
Ironwood is committed to the art and science of
Patient needs shape our business. They inform our drugmaking process. We rely on patients to help us understand and address those unmet needs. Whether we’re transforming knowledge into medicine or tackling the equally challenging task of delivering that medicine to people around the world, patients inspire us.
Shareholders shape our success. Being a shareholder of Ironwood is about more than owning our shares, it's about being an owner of our business. We hope to generate outstanding returns for our shareholders, inspiring their continued support so that we can create more medicines and build an enduring pharmaceutical company.
Employees shape our future. At Ironwood, we’re building a team of talented individuals who embrace the incredibly challenging task of making medicines. All our employees are equity holders, which means we are careful stewards of our resources, and we share the responsibility to build and grow this company.
Our discovery and development processes have generated a product that’s approved in the United States, the European Union and a number of other countries, as well as a robust pi...peline. We hope to continue earning the right to make medicines and, one step at a time, build an enduring pharmaceutical company that helps patients lead better lives.