Description
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.
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 the review of Advertising and Promotional (Ad Prom) materials and accountable for all operational aspects of regulatory submissions providing planning and technical support for Vantive’s products for 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 in support of new and existing marketing authorizations
- Plan and manage complex projects and prioritize workload
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Vantive and external standards
- Maintain appropriate communication within the RA function, BU marketing, and other functions primarily at the project team level
- Communicate proactively and report to regulatory authorities
- Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
- Assess impact of new regulations and provide feedback.
- Set team, group, or service objectives to assure they align with the Regulatory strategy
- Provide technical and strategic input for regulatory decisions
- Support Regulatory Affairs team's ownership of the global Ad Prom process and system
- May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
What You'll Bring
- Bachelor’s degree or country equivalent in 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
- Strong ability to oversee multiple projects in a matrix team environment.
- Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
- Excellent oral and written communication and presentation skills.
- Ability to accomplish results through others
- Ability to lead, coach, and motivate others
- Experience with Veeva Promomats is a plus.
Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $130,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.