FDA Drug/Biologics Regulation Counsel

9-20 yrs required

Full-time

No

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 (.) 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.

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