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 know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.
Purpose of the Role :
As part of the Global Regulatory Affairs organization, this position will interact with regional colleagues (i.e. Middle East and Africa, Latin America, Europe, Asia Pacific, USA etc.
to prepare regulatory submissions needed to maintain approved Drug and Device applications and ensure alignment with current regulations, regulatory guidelines, and manufacturing operations.
Essential Duties and Responsibilities
Interact with non-regulatory support groups (i.e. manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals
Track status and progress of regulatory documentation that will be used for product renewals
Review regulatory documentation
Coordinate and compile responses to regulatory authority renewal questions (under supervision)
Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities (under supervision)
Answer internal queries for assigned products
Maintain Database of Regulatory Requirements for renewals
Bachelor’s degree or country equivalent, preferably in a scientific discipline
Scientific background (i.e., chemistry, microbiology, biochemistry, pharmacy, engineering, etc.) desired
Demonstrated interpersonal skills, detail oriented, and solid organization skills
Able to manage multiple projects and adapt as priorities change
Strong written and oral communication skills (English language)
Identify alternate options to issues and negotiate with country RA
Ability to identify issues and effectively communicate when necessary
Ability to lead and coach others