Description:

The Position:
A Full-Service Law Firm's growing Regulatory Practice is looking to add a Senior FDA Attorney with a minimum of 10 years' experience to our Washington DC office. The attorney will serve as a business advisor to clients, guiding them in a full range of legal matters throughout their life cycle. The attorney will also have the opportunity to gain direct client interaction, business development experience, and significant responsibility for complex and sophisticated legal matters

The Ideal Candidate Will Have Experience in the Following Areas:

Preparing and filing FDA submissions for both innovator and generic drugs, and shepherding applications through the approval process;
Evaluating legal questions involving marketed unapproved drugs including pre-1938 grandfathered drugs, the DESI program, and the application of the Weiss List;
Reviewing OTC drug labeling and promotional materials for FDA compliance and potential regulatory risk;
Preparing and filing 510(k) medical device premarket notifications and premarket approval applications;
Assist contact lenses manufacturers and sellers with issues related to the PMA approval process, the cGMP requirements of the Quality System Regulation / QSR (21 CFR Part 820), pharmacovigilance or adverse event reporting, labeling and marketing, and evaluation of risk for purposes of conducting a market withdrawal or recall;
Understanding the regulation of electronic health records and the digital platforms used for their maintenance and transfer;
Strategies to overcome prescription drug approval delays;
Advising on product labeling, packaging, and cGMP manufacturing requirements;
Product listings and establishment regulations;
Responding to FDA warning letters;
Preparing clients for FDA and USDA facility inspections;
Conducting due diligence reviews prior to sales and acquisitions;
Resolving product seizures by U.S. Customs and obtaining removal from import alert list;
Product recalls and market withdrawals involving both FDA and USDA regulated products such as Rx drugs, foods, meats, and dairy products;
GRAS self-affirmations and notifications;
Reviewing advertising and marketing content for compliance with FTC regulations;
State food and drug regulatory matters including wholesaler/distributor licensing and registration

A minimal portable book of business of at least $500,000 is preferred.

The Company:
We are A Full-Service Law Firm. We are a full-service law firm with more than 350 lawyers and technical professionals who work in collaborative, interdisciplinary practices to serve clients around the world. We work with companies in all kinds of industries, as well as trade associations, nonprofits, educational institutions, governments, family trusts, and high-net-worth individuals. Since our firm's founding in 1848, we've continuously evolved to meet our clients' changing needs and expectations. One thing remains the same: For generations, clients have relied on A Full-Service Law Firm for exceptional legal service and business acumen.

The Location:
We have offices in Wisconsin (Milwaukee, Madison, Manitowoc, Waukesha); Illinois (Chicago); Utah (Cottonwood Heights, Salt Lake City); Colorado (Denver, Broomfield); Texas (Austin); and North Carolina (Charlotte, Raleigh, Wilmington); and Washington D.C. Our contemporary offices spaces are ideal for concentration and collaboration supporting our culture of working together to make great things happen for our Clients.

Job Requirements:
Bring Your Best

Knowledge Base & Education:

J.D. from an ABA accredited law school
Excellent academic credentials
10+ years FDA experience

Adaptability:

Ability to learn and embrace new skills and best practices as the position evolves and Firm needs change
Ability to work well under pressure and meet tight deadlines
Ability to work well independently as well as effectively within a team

Collaboration:
Ability to develop relationships and foster teamwork at all levels of the Firm

Communication:

Excellent interpersonal skills and ability to work effectively with a diverse group of internal and external clients, attorneys, and staff
Excellent oral and written communication skills
Ability to manage confidential information and sensitive situations with tact and discretion

Problem Solving Skills:

Ability and confidence to identify and analyze issues, make decisions, and initiate actions/solutions
Agility to respond to unexpected challenges, including proactively developing innovative solutions to complex problems while maintaining a professional demeanor

Professionalism
Ability to maintain composure and demonstrate good judgment

Other: