FDA Regulatory Attorney – Life Sciences
Location: Flexible / Hybrid / Remote (as applicable)
Position Overview
We are seeking an experienced FDA Regulatory Attorney to support a dynamic life sciences practice focused on clinical development, regulatory strategy, and pre-market approvals. This role offers the opportunity to work directly with innovative pharmaceutical, biotech, and medical device clients navigating complex FDA pathways.
The ideal candidate will bring hands-on FDA regulatory experience and a practical, solution-oriented approach to advising clients on high-impact development and commercialization strategies.
Key Responsibilities
- Provide strategic legal and regulatory counsel across FDA pre-market and clinical development matters
- Advise clients on regulatory pathways, product development strategy, and approval processes
- Support preparation, review, and submission of key regulatory filings (e.g., INDs, NDAs, BLAs, IDEs, 510(k)s, PMAs)
- Engage in direct interactions with FDA and other regulatory agencies, including meeting preparation and response strategy
- Assist clients in navigating evolving FDA requirements, guidance documents, and enforcement trends
- Collaborate with cross-functional stakeholders including clinical, scientific, and regulatory teams
- Support broader life sciences regulatory matters as needed across drug, biologic, and device portfolios
Qualifications
- Prior experience working with FDA regulatory matters in a law firm, government agency, and/or in-house industry role
- Demonstrated exposure to FDA pre-market submissions, clinical development, or regulatory strategy
- Strong understanding of FDA regulatory frameworks applicable to pharmaceuticals, biologics, and/or medical devices
- Excellent written and verbal communication skills, with the ability to translate complex regulatory concepts into practical guidance
- Ability to manage multiple projects in a fast-paced, deadline-driven environment
- A scientific or technical background is helpful but not required
Benefits
Our client offers a robust benefits package to eligible employees, including:
- Medical, dental, and vision coverage
- Federal and state leave programs as required by applicable regulations
- Additional benefits designed to support professional growth and work-life balance