Senior Specialist

Responsibilities

• Develop and execute regulatory project plans with direction
• Identify and elevate key areas of regulatory risk to ensure compliance
• Maintain regulatory files in a format consistent with global requirements
• Maintain awareness of evolving regulatory requirements and identify relevant changes
• Provide regulatory advice to project teams and participate as an active team member
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit regulatory documents in a timely manner
• Maintain and update existing regulatory authorizations
• Prepare, review, and approve labeling and Standard Operating Procedures (SOPs)
• Represent or lead Regulatory Affairs within small project teams

Requirements

• Bachelor’s degree or country equivalent in a scientific discipline
• 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
• Ability to multitask, prioritize, and identify compliance risks
• Excellent interpersonal, communication, and negotiation skills
• Proficiency in technical systems including word processing, spreadsheets, databases, and online research

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, bringing smarter, more personalized care to patients around the world. We foster a culture of courage, trust, and collaboration, empowering our employees to make a meaningful impact on healthcare delivery.