Sr Mgr, Regulatory Affairs

• Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
• Provide technical and strategic input for regulatory decisions aligned with business strategy
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
• Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
• Assess impact of new regulations and provide feedback
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
• Act as primary contact for meetings with regulatory authorities including planning and leadership
• Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
• Plan and manage complex projects and prioritize workload
• Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
• Set team, group, or service objectives to assure they align with the regulatory strategy
• Represent Baxter interests in industry and working groups
• Mentor junior colleagues on US regulatory requirements and submission strategies

• Bachelor's degree or country equivalent in a scientific discipline
• Master's and/or PhD will be preferred
• Minimum of 7-year experience in RA
• Expert Regulatory knowledge
• Sound basis of Scientific (Training/ Communications) knowledge
• Management skills
• Ability to oversee multiple projects in a matrix team environment
• Excellent oral and written communication and presentation skills
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
• Technical and management skills
• Ability to lead, coach, and motivate others
• Ability to accomplish results through others
• Ability to work effectively in multinational/multicultural environment

Master's and/or PhD will be preferred

• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits