Mgr, Regulatory Affairs

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The Role:

As the Group Manager for Regulatory Affairs in Japan, you will play a pivotal role in the Pipeline and On-Market Products Development and Maintenance from a regulatory perspective. You will be responsible for leading the introduction of new products and ensuring the continued success of our existing product portfolio. This is an outstanding opportunity to create a significant impact in the healthcare industry and contribute to the improvement of patient care.

If you are an ambitious regulatory affairs professional with a proven track record of success, we invite you to join our world-class team at Baxter Healthcare. As a Group Manager, you will have the opportunity to make a difference in the lives of patients worldwide by ensuring the quality and compliance of our products. We offer a competitive salary, comprehensive benefits package, and a supportive work environment that values collaboration, innovation, and personal growth.

Responsibilities

• Reporting directly to the Head of Quality Assurance and Regulatory Affairs
• Managing the registration and upkeep of medical devices and drugs, while creating and implementing regulatory plans in line with our business strategy
• Identifying and prioritizing areas of risk, implementing appropriate mitigation plans, and fostering proactive communication within the regulatory affairs team, global marketing, and other cross-functional teams
• Ensuring that registration strategies and deliverables align with project teams and business objectives
• Leading regulatory activities for our portfolio of products, including preparing, reviewing, and approving labeling and J-CTD based on global dossier
• Representing or leading the regulatory affairs function on assigned cross-functional project teams
• Monitoring and proposing solutions for applicable regulatory documentation, continuously identifying areas for improvement
• Making sound regulatory decisions and justifications, and ensuring compliance with applicable regulations and guidelines.

Key requirements:

• A Bachelor's degree is required, and a Master's or PhD will be advantageous
• A Scientific (chemical) or Pharmaceutical background, accompanied by regulatory knowledge is required for this role
• A demonstrated ability with 5 years + in medical device registration, with experience in pharmaceutical drug filing
• Strong management skills, with experience in supervising individuals
• Effective communication and negotiation skills
• Excellent multitasking and prioritization abilities, ensuring efficient management of multiple projects
• The capability to establish relationships with regulatory authorities and effectively communicate regulatory requirements
• Strong written, verbal communication, and presentation skills in Japanese and English (e.g., TOEIC: above 700 or 800)
• Experience working for global companies is desirable.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.