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New York City, NY, United States

FDA And Life Sciences Healthcare Associate Attorney

Attorney

2-10 yrs required

Full-time

No

Job Title: FDA And Life Sciences Healthcare Associate Attorney

Job Overview: A prominent law firm in New York City, NY, is seeking a talented Healthcare & Life Sciences Regulatory Associate Attorney to join its well-regarded national healthcare and life sciences practice. This role will involve advising clients on regulatory, compliance, and transactional matters across a diverse range of healthcare sectors. The firm has earned recognition for its depth in healthcare regulatory work, receiving accolades from leading industry journals and legal ranking organizations. This position is ideal for attorneys looking to deepen their expertise in FDA regulatory compliance within a supportive, collaborative environment.

Duties:

• Provide strategic guidance on FDA regulatory compliance across the product lifecycle, from preclinical stages through to commercial product development.
• Advise on product approvals, labeling, inspections, manufacturing, recalls, 483 responses, adverse event management, and quality agreements.
• Conduct due diligence for life sciences transactions, especially in acquisitions involving regulatory aspects.
• Counsel clients on advertising and promotional practices in compliance with DSHEA, Food Drug and Cosmetics Act, and Federal Trade Commission Act for devices, drugs, dietary supplements, biologics, and cosmetics.
• Offer guidance on additional areas, including Boards of Pharmacy regulations, FDA market denial orders, and cannabis licensure and regulation.
• Support telemedicine-based drug delivery compliance and advise in litigation-adjacent roles related to life sciences issues.

Requirements:

• 3-5 years of experience in FDA regulatory compliance, with a focus on healthcare and life sciences.
• Expertise in preclinical and commercial product development, including regulatory submissions, recalls, and adverse event reporting.
• Experience in advising life sciences clients on regulatory and transactional matters.
• Prior experience in a sophisticated law firm, healthcare, or FDA environment is preferred.

Education:

• JD from an accredited law school with strong academic credentials.

Certifications:

• Admission to the New York State Bar or eligibility for admission.

Skills:

• Strong written and verbal communication skills.
• Ability to analyze and apply complex regulatory frameworks in the life sciences sector.
• Proven track record of providing strategic advice to clients within healthcare and life sciences.

Job Location:

• New York City, NY

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