Manager
The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide regulatory strategy for assigned projects that leads to a reliable and efficient timeline for product approval. The expectation of the position holder will be to understand pertinent regulations and guidance and ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to ensure sufficient and efficient communication through activities such as governance review, project team meetings, planning activities and FDA communications.
Associate Director
Act as Regulatory Affairs (RA) core or subteam member in projects as well as in program teams. Anticipate changes in pertinent regulations and evaluate impact on projects/existing products. Define sound regulatory strategies for assigned products/projects within the team and ensure regulatory compliance with regards to safety and efficacy. The position will link the safety and efficacy regulatory team with internal stakeholders and external stakeholders (regulatory agencies) to ensure comprehensive synergies between regulatory, research, development and business activities in accordance with the strategic plan of the company.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
