Job Summary:
Vantive is seeking an experienced Manager, Regulatory Affairs (Advertising & Promotion) for its Deerfield, Illinois location. This pivotal role involves leading the review of promotional and advertising materials for pharmaceutical and medical device products, ensuring global regulatory compliance, and supporting submissions for various business units. The position requires expertise in regulatory Ad Prom activities and offers an opportunity to shape the global regulatory strategy of a market leader in vital organ therapies.
Key Responsibilities:
Review and approve advertising & promotional materials for drug products and medical devices (Class I, II, III).
Oversee regulatory submissions for new and existing marketing authorizations.
Monitor and interpret applicable regulatory requirements to ensure Vantive's global compliance.
Evaluate technical data, identify risks, and devise regulatory strategies.
Engage with regulatory authorities and provide timely communication and reporting.
Provide technical and strategic regulatory input for cross-functional teams.
Lead and manage complex projects while setting team objectives aligned with regulatory strategy.
Support the global Ad Prom process, systems ownership, and regulatory process improvements.
Mentor and supervise team members, contributing to staffing and performance management decisions.
Required Skills & Qualifications:
Bachelor's degree in a related scientific discipline.
Minimum 5 years of experience in Regulatory Affairs Advertising & Promotion, with project or team management experience.
Strong regulatory knowledge in Ad Prom (MLR) and other regulatory domains.
Scientific and technical expertise in evaluating promotional materials.
Proficiency in managing cross-functional teams and multiple projects.
Excellent interpersonal, negotiation, communication, and presentation skills.
Ability to lead, mentor, and motivate team members.
Familiarity with Veeva Promomats (preferred).
Perks & Benefits:
Competitive annual salary: $112,000 to $155,000 (dependent on experience and location).
Performance-based discretionary bonuses.
Comprehensive health, dental, and vision coverage from day one.
401(k) retirement savings plan (Aon Pooled Employer Plan).
Paid time off (20–35 days) and parental leave.
Educational assistance and flexible spending accounts.
Life, accident, disability, and business travel insurance.
Employee discounts, childcare benefits, and commuting support.
Employee Assistance Program (EAP).
Company Description:
Vantive is a global leader in vital organ therapies, focusing on innovative solutions in kidney care and expanding into life-changing medical technologies. With 70 years of groundbreaking achievements, Vantive is dedicated to improving patients' lives and elevating care standards worldwide.
Work Mode:
Hybrid – Minimum 3 days per week onsite at Deerfield, Illinois.
Call to Action:
Ready to advance your regulatory career with a global healthcare innovator? Apply now to join Vantive and drive impactful change in pharmaceutical and medical device regulatory affairs.
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