Senior Specialists

• 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
• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain regulatory files in a format consistent with requirements
• Maintain awareness of regulatory requirements
• identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and SOP's
• Represent or lead Regulatory Affairs in small project teams

• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary
• Bachelor's degree (or equivalent) in a scientific discipline is required, along with 8-10 years of total experience with a minimum of 2 years of regulatory in a pharmaceutical, medical device, CRO, or similar organization
• Candidates with prior regulatory and/or technical expertise in complex drug product characterization and regulatory submissions - such as Iron colloids, peptides, liposomes, or biologics will be more preferable

Prior regulatory and/or technical expertise in complex drug product characterization and regulatory submissions - such as Iron colloids, peptides, liposomes, or biologics