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Summary:

Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/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

Qualifications:

• Sound basis of Regulatory knowledge
• Scientific Knowledge
• 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 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.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.