Regulatory Affairs Manager

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients—that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Essential Duties and Responsibilities:

• Develop and execute regulatory cluster strategy and plans aligned with business for complex projects including new products and maintenance of licenses/authorizations for existing marketed 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 applicable cluster country regulatory requirements, assure compliance with Baxter and external standards.
• Assess impact of new regulations with regional impact and provide feedback.
• Maintain appropriate communication within the RA function, with cluster Marketing, and with other functions primarily at the project team level.
• Plan and manage complex projects and prioritize workload.
• Ensure regulatory strategy and deliverables are aligned with project teams and business objectives.
• Develop and execute role-based regulatory plans aligned with business needs.
• Work with Country RA teams to align submission strategy and support dossier delivery.
• Represent the RA function on cluster assigned cross-functional project teams.

Education & Experience:

• Bachelor’s degree or country equivalent in a scientific discipline.
• Master’s degree or PhD is an advantage.
• Minimum 8-year experience in drug or medical device RA or QA work including management of people.
• Strong regulatory knowledge on medical device regulatory laws in different countries (preferably SEA).
• Technical knowledge and management skills.
• Ability to manage complex projects and timelines in a matrix team environment.
• Strong interpersonal, communication and presentation skills.
• Strong negotiation skills.
• Ability to lead and coach others.
• Excellent organization skills.

Reasonable Accommodation

Vantive 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. Form Link