Promotional Review Lead — Regulatory Affairs

Leo Pharma GmbH; Madison (NJ); Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Hybrid work opportunities

Job summary

Leo Pharma GmbH invites applications for a Senior Specialist, Regulatory Affairs – Promotional Review to edit LMR review material for inline brands and new products. You will ensure quality submission of marketing materials through Legal, Medical, and Regulatory review and provide back-up support to other LMR Coordinators.

You will coordinate reviewers, manage submission calendars, perform quality control, proofread materials, and partner with Marketing, Medical, Regulatory, Legal, and external

Qualifications

• Bachelor’s Degree or equivalent experience required.
• 3-5 years of LMR related experience or other pharma/biotech experience at minimum Coordinator level.
• Experience of managing a pharma/biotech promotional review committee and processes desirable.
• Very structured and with high level of attention to detail (including proofreading).
• Ability to multi-task and prioritize; excellent organizational and planning skills.
• Ability to work with a team by anticipating needs and adapting to changing situations; demonstrated ability to work effectively with all levels up to and including company leadership team members.
• Very strong interpersonal and communications skills (verbal and written).
• Strong negotiating and analytical skills.
• Willingness to accept high level of responsibility for own actions, along with strong decision-making skills.
• Strong computer skills including advanced Microsoft Word, Power Point, Excel, Adobe Acrobat.

Responsibilities

• Serve as the central point of contact for all LMR submissions and inquiries.
• Coordinate and assign reviewers based on content, audience, product, and review requirements.
• Manage the LMR submission calendar, ensuring visibility into deadlines, review volumes, and business priorities.
• Perform quality control reviews of promotional materials before submission and approval workflows.
• Proofread final marketing materials to ensure alignment with approved content and layouts.
• Partner cross-functionally with Marketing, Medical, Regulatory, Legal, and external agencies to deliver accurate, compliant, and high-quality materials on time.
• Facilitate communication between content owners, reviewers, approvers, and leadership stakeholders throughout the review process.
• Manage promotional review documentation, including policies, SOPs, work instructions, and audit-readiness requirements.
• Support FDA submissions and ensure compliance with applicable regulatory requirements.
• Provide training and ongoing process support to new hires, vendors, and system users.

Skills

Attention to detail

Multi-tasking

Organizational skills

Team collaboration

Interpersonal skills

Negotiation

Analytical skills

Decision making

MS Office proficiency

Adobe Acrobat

Education

Bachelor’s Degree

Tools

Microsoft Word

PowerPoint

Excel

Adobe Acrobat

Job description

Leo Pharma GmbH invites applications for a Senior Specialist, Regulatory Affairs – Promotional Review to edit LMR review material for inline brands and new products. You will ensure quality submission of marketing materials through Legal, Medical, and Regulatory review and provide back-up support to other LMR Coordinators.

You will coordinate reviewers, manage submission calendars, perform quality control, proofread materials, and partner with Marketing, Medical, Regulatory, Legal, and external