Vantive
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.
Is this your next job Read the full description below to find out, and do not hesitate to make an application. 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 operational aspects of regulatory submissions, providing planning and technical support for Vantive's products across one or more business units or countries.
What You'll Be Doing
Review and approve advertising and promotional material for drug products and medical devices (Class I, II, and III).
Initiate, manage, and maintain operational activities supporting new and existing marketing authorizations.
Plan and manage complex projects, prioritizing workload effectively.
Monitor, evaluate, and interpret regulatory requirements to ensure compliance with Vantive and external standards.
Maintain communication within the Regulatory Affairs function, BU marketing, and other teams at the project level.
Proactively communicate and report to regulatory authorities.
Evaluate scientific information, identify deficiencies, and implement strategies to mitigate risks.
Assess the impact of new regulations and provide feedback.
Set team or service objectives aligned with regulatory strategy.
Provide strategic input for regulatory decisions.
Support the ownership of the global Ad Prom process and system within Regulatory Affairs.
May supervise team members, 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.
Expertise in Regulatory knowledge specifically in the Ad Prom (MLR) space and other regulatory functions.
Scientific knowledge relevant to the role.
Strong ability to collaborate across teams and oversee multiple projects in a matrix environment.
Excellent interpersonal, negotiation, and communication skills.
Proven leadership, coaching, and motivational skills.
Experience with Veeva Promomats is a plus.
Vantive supports workplace flexibility, including a minimum of 3 days onsite per week, to foster collaboration and support our mission.
Regarding compensation, the estimated annual base salary ranges from $112,000 to $130,000, with potential for bonuses. Salary offers depend on location, skills, experience, and other factors.
US Benefits at Vantive We offer comprehensive health, dental, vision, life, disability insurance, and a 401(k) plan, among other benefits, starting from day one. Additional perks include flexible spending accounts, educational assistance, paid time off, and family benefits.
Equal Employment Opportunity & Reasonable Accommodation Vantive is committed to diversity and provides accommodations for individuals with disabilities during the application process. We evaluate all applicants without discrimination based on legally protected characteristics.
Recruitment Fraud Notice Be aware of employment scams impersonating Vantive. For protection tips, review our Recruitment Fraud Notice.
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Is this your next job Read the full description below to find out, and do not hesitate to make an application. 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 operational aspects of regulatory submissions, providing planning and technical support for Vantive's products across one or more business units or countries.
What You'll Be Doing
Review and approve advertising and promotional material for drug products and medical devices (Class I, II, and III).
Initiate, manage, and maintain operational activities supporting new and existing marketing authorizations.
Plan and manage complex projects, prioritizing workload effectively.
Monitor, evaluate, and interpret regulatory requirements to ensure compliance with Vantive and external standards.
Maintain communication within the Regulatory Affairs function, BU marketing, and other teams at the project level.
Proactively communicate and report to regulatory authorities.
Evaluate scientific information, identify deficiencies, and implement strategies to mitigate risks.
Assess the impact of new regulations and provide feedback.
Set team or service objectives aligned with regulatory strategy.
Provide strategic input for regulatory decisions.
Support the ownership of the global Ad Prom process and system within Regulatory Affairs.
May supervise team members, 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.
Expertise in Regulatory knowledge specifically in the Ad Prom (MLR) space and other regulatory functions.
Scientific knowledge relevant to the role.
Strong ability to collaborate across teams and oversee multiple projects in a matrix environment.
Excellent interpersonal, negotiation, and communication skills.
Proven leadership, coaching, and motivational skills.
Experience with Veeva Promomats is a plus.
Vantive supports workplace flexibility, including a minimum of 3 days onsite per week, to foster collaboration and support our mission.
Regarding compensation, the estimated annual base salary ranges from $112,000 to $130,000, with potential for bonuses. Salary offers depend on location, skills, experience, and other factors.
US Benefits at Vantive We offer comprehensive health, dental, vision, life, disability insurance, and a 401(k) plan, among other benefits, starting from day one. Additional perks include flexible spending accounts, educational assistance, paid time off, and family benefits.
Equal Employment Opportunity & Reasonable Accommodation Vantive is committed to diversity and provides accommodations for individuals with disabilities during the application process. We evaluate all applicants without discrimination based on legally protected characteristics.
Recruitment Fraud Notice Be aware of employment scams impersonating Vantive. For protection tips, review our Recruitment Fraud Notice.
#J-18808-Ljbffr