Employment Type : Full-Time
Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and...
Employment Type : Full-Time
About us Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The pace of change in society...
Employment Type : Full-Time
Provides leadership in support of the Regeneron portfolio products assigned and platform initiatives. The candidate will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination...
Employment Type : Full-Time
Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is...
Employment Type : Full-Time
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we...