Senior Manager, Regulatory Affairs

Job not on LinkedIn

🔥 13 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $152k - $209k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Baxter International Inc.

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Grant on 2021-04

Healthcare • Manufacturing • Healthcare Insurance

Baxter International Inc. is an innovative, global healthcare leader that offers advanced products, technologies, and therapies to support people in leading healthier, longer lives. The company is committed to meeting the challenges faced by patients, clinicians, and customers in the evolving healthcare landscape, emphasizing resilience and a mission to save and sustain lives.

📋 Description

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

🎯 Requirements

• Bachelor’s degree or country equivalent in a scientific discipline • 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 • Applicants must be authorized to work for any employer in the U.S. • Master’s and/or PhD will be preferred

🏖️ Benefits

• Medical and dental coverage starting on day one • Basic life insurance • Accident insurance • Short-term and long-term disability insurance • Business travel accident insurance • Employee Stock Purchase Plan (ESPP) with discounted company stock • 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching • Flexible Spending Accounts • Educational assistance programs • Paid holidays • Paid time off ranging from 20 to 35 days based on length of service • Family and medical leaves of absence • Paid parental leave • Commuting benefits • Employee Discount Program • Employee Assistance Program (EAP) • Childcare benefits • Discretionary bonuses may be available