Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Legal Manager - Commercial & PMRC

Legal Counsel & Legal SupportPosted on Nov 6

Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

An LL.B. or LL.M. from a recognized college or university and approximately 5+ years of post-qualification legal experience, including at least 2+ years supporting pharmaceutical promotional or 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.
Experience with or knowledge of global pharmaceutical advertising and promotional requirements is strongly preferred.
Experience with Vodori or a similar pharmaceutical promotional review and approval platform is preferred.
Experience supporting innovator and/or 505(b)(2) pharmaceutical products is preferred.
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.

Responsibilities

Serve as a primary legal reviewer in the 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.

Desired Qualifications

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.

At Azurity, we're redefining medicine for the real world. Most medicines are designed for how they're approved; ours are built for real life. That shift drives everything we do. We challenge the status quo — repurposing proven molecules with intention, reimagininghow therapies are designed, delivered, and accessed so they work in the realities of everyday life. And with a diversified and growing portfolio, we bring the agility, scale, and global reach to deliver meaningful solutions to patients, providers, and healthcare systems around the world. Because medicine should fit into life, not force life to fit around it. With more than 70 medicines across 11 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com and LinkedIn.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

About the Role

Azurity’s Legal team supports a growing portfolio of pharmaceutical products in the U.S. and globally. We are seeking a dynamic, commercially oriented attorney to serve as a key legal resource for promotional review and commercial activities, partnering closely with Commercial, Medical, Regulatory, Compliance, and other cross-functional stakeholders to support compliant product promotion and commercialization.

Principal Responsibilities

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.

Qualifications and Education Requirements

LL.B. / LL.M. from a recognized college or university, with approximately 5+ years of post-qualification legal experience, including 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.
Experience with or knowledge of global pharmaceutical advertising and promotional requirements strongly preferred.
Experience with Vodori or a similar pharmaceutical promotional review and approval platform preferred.
Experience supporting innovator and/or 505(b)(2) pharmaceutical products preferred.
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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

About the Company

Azurity Pharmaceuticals

Reformulates established medicines into alternative doses

Azurity Pharmaceuticals focuses on developing specialized dose forms of existing medicines to meet unmet patient needs in the U.S., especially for those who have difficulty swallowing or require precise dosing. It creates formulations like oral suspensions across therapeutic areas including cardiovascular, CNS, endocrine, GI, anti-infective, and oncology, marketed to providers, hospitals, and pharmacies. Unlike firms that launch new chemical entities, Azurity expands access by reformulating approved drugs into tailored, regulatory-compliant products such as FIRVANQ, HORIZANT, GLIADEL Wafer, SOTYLIZE, VIVIMUSTA, and others. Its goal is to improve patient outcomes by making FDA-approved medicines easier to use and accessible for overlooked patient populations.

Company size: 201-500
Company stage: Growth Equity (Venture Capital)
Total funding: $182.2M
Headquarters: Woburn, MA
Founded: 2000

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