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United States
Remote only
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Promotional Review Specialist based in the United States.
Join a growing life sciences organization dedicated to advancing regenerative medicine through innovative products and high-quality solutions. In this fully remote role, you will coordinate the end-to-end review and approval of promotional, advertising, and commercial materials within a regulated environment. You will serve as a central point of contact for internal teams and external partners, ensuring submissions meet established requirements and review processes remain efficient. Working closely with Regulatory Affairs, Legal, Medical, Compliance, Marketing, and Commercial stakeholders, you will facilitate feedback, manage documentation, and maintain approval records. You will also monitor review timelines, identify potential bottlenecks, and contribute to continuous process improvement. This is an excellent opportunity for a detail-oriented regulatory professional to strengthen compliance, support cross-functional collaboration, and help ensure promotional materials meet applicable standards.
Promotional review coordination: Manage the complete review and approval lifecycle for advertising, promotional, and other applicable commercial materials, ensuring reviews progress efficiently and align with established procedures.
Submission readiness and quality control: Screen incoming submissions to confirm that materials are complete, properly supported, and ready for review before entering the approval process.
Stakeholder and partner coordination: Act as the primary liaison for internal teams and external business partners, communicating submission requirements, review expectations, deadlines, and status updates.
Cross-functional collaboration: Work closely with Compliance, Clinical and Medical, Marketing, Legal, Regulatory Affairs, Commercial, and other relevant departments to facilitate consistent reviews and timely decisions.
Issue identification and escalation: Identify and escalate potential concerns involving promotional claims, labeling, intended use, brand guidelines, internal policies, and applicable regulatory or compliance requirements to the appropriate reviewers.
Timeline and workflow management: Monitor review progress, outstanding actions, and deadlines; follow up with reviewers and escalate delays or bottlenecks to maintain efficient turnaround times.
Documentation and records management: Maintain accurate approval records, version histories, review comments, and final approved materials, ensuring documentation remains complete, traceable, and accessible for audits or inspections.
Review committee administration: Coordinate promotional review committee meetings by preparing agendas and materials, documenting reviewer feedback and decisions, and tracking follow-up actions through completion.
Performance reporting: Develop and maintain promotional review metrics to monitor workload, review cycle times, outstanding submissions, and overall process effectiveness.
Continuous improvement: Support the development and refinement of promotional review workflows, standard operating procedures (SOPs), submission standards, and best practices to improve consistency and operational efficiency.
Education: Bachelor's degree in life sciences, pharmacy, communications, regulatory affairs, healthcare, business, or a related discipline.
Relevant experience: At least three years of experience in promotional review, regulatory affairs, advertising and promotion review, medical review support, or a related regulatory or compliance function.
Industry knowledge: Professional experience in a regulated life sciences environment, such as pharmaceuticals, biotechnology, or medical devices.
Promotional review expertise: Strong understanding of promotional material review processes, submission requirements, approval workflows, and document control practices.
Regulatory and compliance awareness: Familiarity with advertising, labeling, promotional requirements, and the importance of maintaining compliant, well-supported commercial materials.
Organizational skills: Excellent attention to detail and the ability to coordinate multiple review cycles, manage competing priorities, track outstanding actions, and meet deadlines.
Communication skills: Strong written and verbal communication skills, with the ability to provide clear guidance, facilitate reviewer feedback, and collaborate effectively with stakeholders across different functions.
Problem-solving and initiative: Ability to identify workflow issues, anticipate potential delays, escalate concerns appropriately, and contribute to practical process improvements.
Preferred regulatory experience: Previous experience within a Regulatory Affairs department is an advantage.
External partner management: Experience coordinating with agencies, external business partners, or third parties involved in promotional material review or content development is preferred.
Review management systems: Familiarity with promotional review platforms such as Veeva PromoMats, Vodori, Aprimo, or similar systems is beneficial.
Documentation and lifecycle management: Knowledge of material lifecycle management, submission standards, version control, and audit documentation practices is desirable.
Professional certification: Regulatory Affairs Certification (RAC) or a similar credential is preferred.
Remote working capabilities: Ability to work independently in a home-office environment with minimal distractions while maintaining effective communication and reliable follow-through.
Competitive salary: Annual compensation ranging from $70,000 to $85,000, depending on qualifications and experience.
Annual bonus opportunity: Eligibility for an annual bonus of up to $3,000.
Remote work: Fully remote position based in the United States.
Healthcare coverage: Medical, dental, and vision insurance.
Retirement savings: 401(k) retirement plan with a company match of up to 6%.
Paid time off: Paid time off to support personal needs and work-life balance.
Paid holidays: Holiday pay as part of the overall benefits package.
Disability coverage: Short-term and long-term disability insurance.
Parental support: Paid parental leave.
Professional development: Opportunities to develop regulatory expertise, strengthen cross-functional skills, and contribute to process innovation.
Collaborative culture: Work in an environment that values accountability, adaptability, continuous learning, customer focus, and inclusion.
Meaningful industry impact: Contribute to the quality, integrity, and compliance of promotional activities within the regenerative medicine sector.
