FDA Drug/Biologics Regulation Counsel

Job Title: FDA Drug/Biologics Regulation Counsel

Location: New York City, NY

Overview: Alaw firm is seeking an experienced FDA Drug/Biologics Regulation Counsel with over 10 years of industry experience in drug and biologics development. The ideal candidate will possess in-depth expertise in FDA regulation of drugs, biologics, cellular and gene therapy products and have a strong track record of counseling biopharma companies at all stages of development.

Duties:

• Provide strategic guidance to biopharma companies on FDA regulatory matters.
• Prepare companies for pre-IND and pre-NDA/BLA meetings.
• Review INDs, NDAs/BLAs, and other submissions to the FDA.
• Negotiate clinical trial endpoints with the FDA.
• Prepare for OTP INTERACT meetings.
• Review briefing packages and provide strategic input.
• Offer guidance on pipeline development, FDA designations, exclusivity analysis, PTE calculations, and Orange Book listings.
• Advise on pharmacovigilance and adverse event reporting obligations.
• Counsel companies on clinical study close-out procedures.

Requirements:

• Minimum 10+ years of industry experience in drug/biologics development.
• Deep expertise in FDA regulation of drugs, biologics, cellular, and gene therapy products.
• Experience counseling biopharma companies in all stages of development.
• Stellar academic credentials.
• Excellent verbal, written, and interpersonal skills.
• Work experience at FDA CBER/CDER preferred.

Education & Certifications:

• Juris Doctor (J.D.) degree from an accredited law school.
• Admission to the New York State Bar (or ability to waive in).
• Additional certifications related to FDA regulation are preferred.

Skills:

• Strong understanding of FDA regulatory processes.
• Exceptional analytical and problem-solving skills.
• Ability to communicate complex regulatory concepts clearly and effectively.
• Proficient in legal research and writing.
• Negotiation skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Benefits Offered:

• Monthly wellness reimbursements.
• 24/7 emotional and behavioral health support and virtual counseling.
• Healthcare coverage for employees and dependents.
• Family-building benefits include IVF, adoption, surrogacy, and egg-freezing.
• Paid parental leave.
• Career coaching and support for working parents.
• Health savings accounts, flexible spending accounts, and retirement plans.
• Pretax commuter and parking benefits.
• Life and disability insurance options.
• Various voluntary insurance options include long-term care, critical illness, and pet insurance.
• Firm-paid CLE, bar review fees, and bar dues.
• Medicare consulting.

This Vault Law 100 and one of the Best Law Firm in the Emerging Companies & Venture Capital firm boasts cutting-edge clients, pleasant people, and a flexible work/life balance. The firm is a global player with very deep tech roots and has been ranked among the top 10 M&A advisors in the nation. As the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, the firm is appealing to associates for fostering an entrepreneurial and collaborative environment across its attorney ranks, emphasizing the importance of mentorship, career growth, and building leadership and relationship skills with clients and colleagues. Compensation at this firm is competitive with peer firms in the region.