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Summary:
Under limited supervision responsible for the implementation of global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Support regulatory activities relating to specific portfolio of global products/projects.
Essential Duties and Responsibilities:
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With direction, develop and execute regulatory project plans
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Identify and elevate key areas of regulatory risk
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Maintain regulatory files in a format consistent with requirements
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Maintain awareness of regulatory requirements; identify relevant requirements
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Participate as an active team member and provide regulatory advice to project teams as required
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Respond to questions from regulatory authorities within strict timelines
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Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
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Maintain and update existing regulatory authorizations
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Support regulatory activities relating to specific portfolio of products/projects
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Prepare, review, and approve labeling and SOP’s
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Represent or lead Regulatory Affairs in small project teams
Qualifications:
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Knowledge of regulations
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Scientific knowledge
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Project management skills
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Manage multiple projects and deadlines
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Ability to multitask and prioritize
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Interpersonal and communication skills
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Negotiation skills
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Technical system skills (e.g., word processing, spreadsheets, databases, online research)
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Ability to identify compliance risks and escalate when necessary
Education and/or Experience:
Bachelor’s degree or country equivalent in a scientific discipline. Minimum of 2 years regulatory experience along with 8-10 years total experience within a pharmaceutical and/or medical device company, CRO, or similar organization.
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.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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