Legal Manager – Commercial & PMRC

Overview

Serve as a commercially oriented legal resource for pharmaceutical promotional review and commercial activities, supporting a growing portfolio of products in the U.S. and globally.

What you'll do

• Serve as a primary legal reviewer in Azurity's Promotional Materials Review Committee (PMRC/MLR) process, reviewing U.S. and global promotional and non-promotional materials and advising on applicable legal and compliance requirements.
• Provide legal advice on prescription and over-the-counter pharmaceutical advertising, promotional messaging and activities, including sales and speaker materials, digital and social media, training materials, scientific communications, disease awareness materials, patient support materials, payor materials, and advisory board materials.
• Partner with Commercial, Medical, Regulatory, Compliance, and other stakeholders to advise on compliant commercial strategies, brand plans, campaigns, and tactics, including appropriate claims, messaging, and supporting materials.
• Help oversee and continuously improve the PMRC/MLR review process, including workflows, governance, escalation pathways, consistency of review, and development of practical guidance and best practices.
• Proactively identify, analyze, and assess legal and compliance risks relating to Azurity products and commercial activities, including risks arising under applicable U.S. and global pharmaceutical advertising and promotional requirements.
• Draft, review, and negotiate commercial agreements, including marketing, sales and commercial operations agreements, statements of work, consulting arrangements, and change orders.
• Provide legal support on other commercial, compliance, and cross-functional matters as needed.

What you'll need

• LL.B. / LL.M. from a recognized college or university.
• Approximately 5+ years of post-qualification legal experience.
• At least 2+ years of experience supporting pharmaceutical promotional/MLR review for products marketed in the U.S.
• Demonstrated experience reviewing pharmaceutical promotional and non-promotional materials and advising Commercial, Medical, Regulatory, and Compliance stakeholders.
• Strong working knowledge of U.S. pharmaceutical laws, regulations, and industry requirements, including the Anti-Kickback Statute, False Claims Act, HIPAA, and Sunshine Act, as applicable to pharmaceutical commercial activities.
• Familiarity with FDA requirements and principles governing prescription drug advertising and promotion, including claims, fair balance, substantiation, and scientific communications.
• Excellent written and verbal communication skills, with the ability to provide practical, business-oriented legal guidance and work effectively with stakeholders across geographies and functions.

Nice to have

• Experience with or knowledge of global pharmaceutical advertising and promotional requirements.
• Experience with Vodori or a similar pharmaceutical promotional review and approval platform.
• Experience supporting innovator and/or 505(b)(2) pharmaceutical products.

Details

• Location: Hyderabad, India.