Application deadline:Location: Madison 07940, New Jersey, United States
Contract type: Permanent
Job ID: 4938
Role DescriptionHelp Shape Compliant Healthcare Communications That Make a Difference. Your Role: As a Senior Specialist, Regulatory Affairs - Promotional Review, you would be the editor of all Legal Medical Regulatory (LMR) review material for both in-line brands and new products. Additionally, you will ensure quality submission of Marketing materials through Legal, Medical, Regulatory review. Will provide back-up support to other LMR Coordinators when needed.
Your Responsibilities: - Serve as the central point of contact for all Legal, Medical, and Regulatory (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.
Your 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 re-view committee and processes desirable.
- Very structured and with high level of attention to detail (including proof-reading)
- 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.
The base salary range for this position is
$100,000-125,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.
