Assistant General Counsel - FDA Regulatory & Commercial

Overview

This role is part of a Regulatory and Commercial Law team providing legal advice and counsel related to the commercialization of pharmaceutical products. The position supports multiple therapeutic areas including cardiovascular, hematology, rare disease, oncology, obesity, and new product launches. The legal counsel will work closely with internal teams such as commercial, medical affairs, regulatory, HEOR, corporate affairs, and compliance.

This position is based in Sleepy Hollow, NY, requiring onsite presence four days per week. Hybrid or fully remote arrangements are not available.

Responsibilities

• Provide strategic and business-focused legal and risk counseling for products and product candidates from development through commercialization.
• Advise on healthcare regulatory matters including regulatory labeling, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
• Understand client teams' strategic and tactical objectives to advise on brand and medical planning, developing innovative legal solutions aligned with business priorities and regulatory requirements.
• Counsel on all aspects of product commercialization such as launch preparation and execution, market development, disease awareness, product communication, advertising, promotion, and strategic brand planning.
• Ensure compliance with applicable laws, regulations, policies, procedures, and controls within supported business areas.
• Advise on data disclosures following clinical development milestones via press releases and medical congresses, ensuring compliance with relevant laws and regulations.
• Collaborate with other legal functions including litigation, intellectual property, compliance, and transactions to provide integrated legal support and timely information sharing.

Requirements

• Juris Doctor (JD) degree with excellent law school credentials.
• Licensed to practice law in New York or eligible for licensure as a registered in-house counsel.
• Minimum of 10 years of legal experience, including in-house roles at pharmaceutical or biotechnology companies and experience at nationally recognized law firms specializing in pharmaceutical and healthcare law.
• Previous experience as a product attorney in the pharmaceutical or biotechnology industry is preferred.
• Ability to manage multiple priorities in a dynamic environment.
• Excellent oral and written communication skills with the ability to present complex information clearly and concisely.
• Proven ability to build strong client relationships and influence leadership while assessing and managing risks in a regulated environment.
• Strong analytical skills, learning agility, and a solid aptitude for science and data analysis.

Compensation & Benefits

• Annual salary range: $238,400 to $397,300.
• Comprehensive benefits package may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off; and paid leaves such as military and parental leave.

Location

• Sleepy Hollow, New York.
• Onsite presence required four days per week; hybrid or remote work options are not available for this role.