Regulatory Promotional Review Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the review and approval process of advertising, promotional, and other relevant commercial materials throughout their lifecycle.

• Conduct submission-readiness assessments to ensure that materials are thorough, properly supported, and prepared for review.

• Act as the primary liaison for the promotional review process among internal stakeholders and external business partners.

• Offer guidance on submission requirements, review expectations, timelines, and current status.

• Collaborate with Compliance, Clinical/Medical, Marketing, Legal, Regulatory Affairs, Commercial, and other relevant departments.

• Identify and escalate potential review issues concerning claims, labeling, intended use, internal policies, brand guidelines, or other specifications.

• Track review progress, timelines, and outstanding actions; follow up with reviewers and escalate any delays or bottlenecks.

• Maintain documentation related to promotional reviews, approval records, version control, and final approved materials.

• Organize promotional review committee meetings, including agendas, meeting materials, reviewer feedback, decisions, and follow-up actions.

• Ensure that promotional review records are preserved and accessible for audits or inspections.

• Develop and sustain promotional review metrics for visibility into workload, cycle-time monitoring, and process enhancement.

• Assist in the development and ongoing improvement of promotional review workflows, standard operating procedures (SOPs), and best practices.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, communications, regulatory affairs, healthcare, business, or a related discipline.

• Over 3 years of experience in promotional review, regulatory affairs, advertising and promotion review, medical review support, or a related compliance/regulatory role.

• Experience in a regulated life sciences sector, such as medical devices, pharmaceuticals, or biotechnology.

• Strong comprehension of promotional material review processes and document control practices.

• Exceptional organizational abilities with the capacity to manage multiple review cycles and deadlines.

• Excellent written and verbal communication skills.

• Capability to collaborate effectively across cross-functional teams and handle competing priorities.

• Experience in a Regulatory Affairs function is preferred.

• Familiarity with working alongside external business partners, agencies, or other third-party entities is preferred.

• Knowledge of promotional review systems such as Veeva PromoMats, Vodori, Aprimo, or similar platforms is preferred.

• Understanding of advertising, labeling, and promotional requirements in regulated settings is preferred.

• Awareness of material lifecycle management, submission standards, and audit documentation practices is preferred.

• Regulatory Affairs Certification (RAC) or a similar credential is preferred.

• Ability to move or lift objects weighing up to 25 pounds.

• Frequent (>75%) stationary position while utilizing digital displays.

• Frequent (>75%) fine manipulation using hands and fingers.

🏝️ Benefits

• Annual bonus opportunity of up to $3,000.

• Paid Time Off (PTO).

• 401(k) plan with up to a 6% company match.

• Holiday pay.

• Comprehensive medical, dental, and vision insurance.

• Short-term and long-term disability coverage.

• Paid parental leave.

• Certified Great Place to Work® workplace culture.