Regulatory Promotional Review Specialist

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

📋 Description

• Oversee the evaluation and authorization of advertising, promotional, and other relevant commercial materials throughout the review process.

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

• Act as the key 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.

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

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

• Maintain records of promotional review documentation, approval records, version control, and final approved materials.

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

• Ensure that promotional review records are kept and accessible for audit or inspection purposes.

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

• Assist in the development and continuous refinement of promotional review workflows, 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 function.

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

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

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

• Excellent written and verbal communication skills.

• Capability to work efficiently across cross-functional teams and juggle competing priorities.

• Experience in a Regulatory Affairs function is preferred.

• Experience collaborating with external business partners, agencies, or other third parties is preferred.

• Familiarity with promotional review systems like Veeva PromoMats, Vodori, Aprimo, or similar platforms is preferred.

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

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

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

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

• Frequent (>75%) stationary position (standing or sitting) while using 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.

• Medical, dental, and vision insurance.

• Coverage for short-term and long-term disability.

• Paid parental leave.