Senior Specialist

Responsibilities

• Develop and execute regulatory project plans to implement global regulatory strategies
• Obtain and maintain marketing authorizations for specific product portfolios
• Identify and elevate key areas of regulatory risk to ensure compliance
• Maintain regulatory files and update existing regulatory authorizations
• Compile and submit regulatory documents in a timely manner according to requirements
• Respond to inquiries from regulatory authorities within strict timelines
• Prepare, review, and approve labeling and Standard Operating Procedures (SOPs)
• Provide regulatory advice to project teams and represent Regulatory Affairs in small project groups

Requirements

• Bachelor’s degree in a scientific discipline or country equivalent
• Minimum of 2 years of regulatory experience within a pharmaceutical or medical device company, CRO, or similar organization
• Strong knowledge of regulatory requirements and scientific principles
• Proven project management skills with the ability to manage multiple deadlines
• Proficiency in technical systems including word processing, spreadsheets, and databases
• Excellent interpersonal, communication, and negotiation skills
• Ability to multitask, prioritize, and identify compliance risks

About the Company

Baxter is a global healthcare leader dedicated to saving and sustaining lives. Since 1931, we have been at the forefront of innovation, redefining healthcare delivery to provide smarter, more personalized care to patients around the world. Our culture is driven by courage, trust, and collaboration.