Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Act as the Global Regulatory Lead for Baxter’s hemostat and sealant products classified as biologic/combination products.

• Offer technical and strategic insights for regulatory decisions that align with business objectives.

• Identify and prioritize critical risk areas while ensuring the execution and follow-up of mitigation strategies.

• Monitor, assess, and interpret relevant regulatory requirements to ensure compliance with both Baxter and external standards.

• Evaluate the implications of new regulations and provide constructive feedback.

• Analyze technical and scientific data, identify gaps, and implement risk-remediation strategies.

• Serve as the primary liaison for meetings with regulatory authorities, including planning and leading those discussions.

• Facilitate communication within Regulatory Affairs, Global Marketing, and other functions at the project-team level.

• Organize and oversee complex projects while effectively prioritizing workloads.

• Initiate, manage, and sustain operational activities that support both new and existing marketing authorizations.

• Establish team, group, or service objectives that are in line with regulatory strategy.

• Advocate for Baxter’s interests in industry forums and working groups.

• Guide junior colleagues on U.S. regulatory requirements and submission strategies.

⛳️ Requirements

• Bachelor’s degree or equivalent from another country in a scientific field.

• At least 7 years of experience in Regulatory Affairs.

• In-depth knowledge of regulatory practices.

• Strong foundational understanding of scientific knowledge related to training and communications.

• Proven management capabilities.

• Ability to oversee multiple projects within a matrix team environment.

• Exceptional oral and written communication and presentation skills.

• Demonstrated strong interpersonal and collaborative abilities, including the diplomacy to manage conflicting priorities.

• Technical and management proficiencies.

• Capability to lead, coach, and inspire others.

• Proven ability to achieve results through collaborative efforts.

• Competence to function effectively in a multinational and multicultural setting.

• Applicants must have authorization to work for any employer within the U.S.

• A Master's degree and/or PhD is preferred.

🏝️ Benefits

• Medical and dental coverage beginning on the first day of employment.

• Basic life insurance provided.

• Accident insurance coverage.

• Short-term and long-term disability insurance options.

• Business travel accident insurance.

• Employee Stock Purchase Plan (ESPP) available with discounted company stock.

• 401(k) Retirement Savings Plan (RSP) featuring employee contributions and company matching.

• Flexible Spending Accounts offered.

• Support for educational assistance programs.

• Paid holidays included.

• Paid time off ranging from 20 to 35 days based on tenure.

• Family and medical leave options available.

• Paid parental leave included.

• Commuting benefits offered.

• Employee Discount Program available.

• Access to an Employee Assistance Program (EAP).

• Childcare benefits provided.

• Discretionary bonuses may be available.