Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We're looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Responsible for defining regulatory strategies and submissions for drugs and medical devices in support of new and existing marketing authorizations for Acute Therapies business unit /countries.
Essential Duties and Responsibilities
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP's for compliance with local and global regulations
Sound basis of Regulatory knowledge
Scientific Knowledge (international Medical Device & Drugs regulations and international standards)
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Education and/or Experience
Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years' regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage.
Experience in CMC, management of European procedures and/or FDA for new registrations as variations/renewals is strongly recommended
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to ~~~ and let us know the nature of your request along with your contact information.
Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.