FDA Associate - Drugs, Biologics, Medical Devices (Mid-Level)

Venable LLP's Food and Drug Law Group seeks a midlevel with a minimum of 4 years of experience to join the practice in the Washington, DC office.

Our team advises life sciences companies on complex U.S. Food and Drug Administration (FDA or the Agency) regulatory matters involving drugs, biologics, medical devices, and combination products. The practice emphasizes strategic, individualized counseling across the full FDA medical product development lifecycle, from early stage development through commercialization and post-market compliance. Our team specialized in products regulated by FDA under the Federal Food Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHSA) among other federal statutes.

In this role, the successful candidate will:
* Review, interpret, and apply applicable Federal statutes, regulations and guidance documents to specific medical product development efforts and legal challenges.
* Review, interpret, and draft legal, scientific and technical materials in support of ourclient's FDA regulatory strategy, providing regulatory analysis and courses of action, and support FDA submissions and engagement.
* Work closely with our Partners on tailored FDA regulatory strategies informed by a deep understanding of both the applicable FDA regulatory framework and each client's technology, development objectives, and commercial goals.
* Support FDA submissions and regulatory pathways, including Type A, B, C, D and Interact Meetings, INDs, NDAs (505(b)(1) and (2)), BLAs, and EUAs for drugs and biologics as well asand medical device submissions (Q-Subs, IDEs, 510(k), PMA, and De Novo applications).
* Advise on GxP compliance, expedited approval pathways, Hatch-Waxman and BPCIA marketing exclusivity and incentive programs (e.g., prioriy review vouchers), product labeling, REMS, and advertising and promotion.
* Counsel on FDA compliance and enforcement matters, including responses to Form 483 observations and warning letters.
* Assist with regulatory advocacy, FDA rulemaking, and legislative or policy developments affecting the FD&C Act and PHSA.
* Advise on public-private research and developments (R&D) partnerships and strategic collaborations with Federal agencies (e.g., DoD/DOW, BARDA, NIH, etc.).
* Draft, review and negotiate research, development, and commercialization agreements, including licenses of Federal technology, CRADAs, FAR and DFAR contracts, other transaction agreements (OTAs), cooperative agreements and grants, material transfer agreements, and other vehicles for government collaboration.

The qualified candidate has:
* Strong regulatory drafting, analytical, and client-service skills.
* Experience advising on FDA regulatory matters for life sciences products by applying applicable statutes, regulations and guidance documents to specific product development efforts.
* Experience reviewing, interpreting, and drafting legal, scientific and technical materials in support of a company's FDA regulatory strategy, providing regulatory analysis and courses of action, and supporting FDA submissions and engagement
* Ability to read, analyze, and draft legal, scientific and technical materials with accuracy and clarity. Candidates must hold a juris doctorate degree from an accredited law school and be admitted to and in good standing with the relevant jurisdiction's bar. Please include law school transcripts and a writing sample with submissions.
* Ideal candidates will hold a technical degree (e.g., biochemistry, mechanical engineering, etc.). Exposure to adjacent legal areas (e.g., CMS coverage and reimbursement or intellectual property prosecution) also advantageous.