Vantive Health LLC
Manager, Regulatory Affairs (Ad Prom)
Vantive Health LLC, Deerfield, Illinois, United States, 60015
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.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. We believe Vantive will not only build our leadership in the kidney care space, but 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 mediocrity. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Your Role at Vantive: The Manager of Regulatory Affairs-Advertising/Promotion
reports to the Sr. Manager, Global Regulatory Affairs-Advertising & Promotion and is responsible for reviewing advertising and promotional materials, and managing all operational aspects of regulatory submissions. This role provides planning and technical support for Vantive’s products across one or more business units/countries.
What You'll Be Doing
Review and approve advertising and promotional material (Drug Products, Medical Devices, Class I, II, and III products).
Initiate, manage, and maintain operational activities supporting new and existing marketing authorizations.
Plan and manage complex projects, prioritize workload.
Monitor, evaluate, and interpret regulatory requirements, ensuring compliance with Vantive and external standards.
Maintain communication within the RA function, BU marketing, and other functions at the project team level.
Proactively communicate and report to regulatory authorities.
Evaluate technical and scientific information, identify deficiencies, and implement strategies to remediate risks.
Assess impacts of new regulations and provide feedback.
Set team or service objectives aligned with Regulatory strategy.
Provide technical and strategic input for regulatory decisions.
Support the Regulatory Affairs team’s ownership of the global AdProm process and system.
May supervise individuals, including mentoring, performance management, and staffing decisions.
What You'll Bring
Bachelor’s degree or equivalent in a related scientific discipline.
Minimum of 5 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects.
Expert regulatory knowledge in the Ad Prom (MLR) space and other regulatory functions.
Scientific knowledge.
Strong ability to work with cross-functional teams.
Ability to oversee multiple projects in a matrix environment.
Excellent interpersonal, collaboration, and negotiation skills.
Excellent oral and written communication and presentation skills.
Ability to lead, coach, and motivate others.
Experience with Veeva Promomats is a plus.
Vantive supports flexible work arrangements, including a minimum of 3 days onsite per week, to facilitate collaboration and support our mission.
Our compensation range for this position is estimated between $112,000 and $130,000 annually, with potential for bonuses. Salary is determined based on location, skills, experience, and other factors. For more details, please discuss with your recruiter.
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Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. We believe Vantive will not only build our leadership in the kidney care space, but 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 mediocrity. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Your Role at Vantive: The Manager of Regulatory Affairs-Advertising/Promotion
reports to the Sr. Manager, Global Regulatory Affairs-Advertising & Promotion and is responsible for reviewing advertising and promotional materials, and managing all operational aspects of regulatory submissions. This role provides planning and technical support for Vantive’s products across one or more business units/countries.
What You'll Be Doing
Review and approve advertising and promotional material (Drug Products, Medical Devices, Class I, II, and III products).
Initiate, manage, and maintain operational activities supporting new and existing marketing authorizations.
Plan and manage complex projects, prioritize workload.
Monitor, evaluate, and interpret regulatory requirements, ensuring compliance with Vantive and external standards.
Maintain communication within the RA function, BU marketing, and other functions at the project team level.
Proactively communicate and report to regulatory authorities.
Evaluate technical and scientific information, identify deficiencies, and implement strategies to remediate risks.
Assess impacts of new regulations and provide feedback.
Set team or service objectives aligned with Regulatory strategy.
Provide technical and strategic input for regulatory decisions.
Support the Regulatory Affairs team’s ownership of the global AdProm process and system.
May supervise individuals, including mentoring, performance management, and staffing decisions.
What You'll Bring
Bachelor’s degree or equivalent in a related scientific discipline.
Minimum of 5 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects.
Expert regulatory knowledge in the Ad Prom (MLR) space and other regulatory functions.
Scientific knowledge.
Strong ability to work with cross-functional teams.
Ability to oversee multiple projects in a matrix environment.
Excellent interpersonal, collaboration, and negotiation skills.
Excellent oral and written communication and presentation skills.
Ability to lead, coach, and motivate others.
Experience with Veeva Promomats is a plus.
Vantive supports flexible work arrangements, including a minimum of 3 days onsite per week, to facilitate collaboration and support our mission.
Our compensation range for this position is estimated between $112,000 and $130,000 annually, with potential for bonuses. Salary is determined based on location, skills, experience, and other factors. For more details, please discuss with your recruiter.
#J-18808-Ljbffr