Senior FDA Attorney

Michael Best & Friedrich LLP; Washington (District of Columbia); On-site; USD 180,000 - 260,000; Full time

Job summary

Michael Best & Friedrich LLP's Regulatory Practice is seeking a Senior FDA Attorney with 10+ years of FDA experience. The ideal candidate will be located in Washington DC but we accept applicants from Austin, Chicago, Denver, Madison, Milwaukee, Raleigh and SLC.

The attorney will advise clients across the life cycle of regulatory matters with direct client interaction and business development opportunities.

Qualifications

• J.D. from ABA-accredited law school and admission to practice in the U.S.
• 10+ years of FDA experience advising on regulatory matters.
• Ability to learn and adapt to evolving FDA and related regulations.

Responsibilities

• Provide strategic regulatory counsel on FDA submissions and compliance.
• Advise on labeling, advertising, and risk management for drugs and devices.
• Lead and manage client interactions, negotiations, and due diligence.
• Prepare and file FDA submissions and FDA/USDA related assistance as needed.
• Help guide clients through inspections, enforcement actions, and market withdrawals.

Skills

FDA regulatory expertise

Legal advisory

Business development

Education

J.D. from ABA-accredited law school

Job description

Michael Best & Friedrich LLP’s growing Regulatory Practice is looking to add a Senior FDA Attorney with a minimum of 10 years’ experience. The ideal candidate will be located in Washington DC but we will accept applications from candidates in Austin, Chicago, Denver, Madison, Milwaukee, Raleigh and SLC. 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.

• Washington DC, Austin, Chicago, Denver, Madison, Milwaukee, Raleigh and SLC
• J.D. from an ABA accredited law school
• Excellent academic credentials
• 10+ years FDA experience
• 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
• 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
• Valid authorization to work in the U.S.
• Minimum portable book of business of $500,000

Why You Should Apply

At Michael Best, we are proud to offer a comprehensive and competitive Total Rewards package that provides a variety of resources designed to enhance its employees’ overall well-being, both at work and at home. Competitive base pay, outstanding benefits, opportunities for learning and growth, programs designed to help you plan for the future, and perks that inspire your downtime are all part of our total compensation package.

Learning & Growth

Total Compensation

Planning for the Future

Culture & Workplace

Learning & Growth

We are committed to fostering an environment where every team member can thrive both personally and professionally. It's why we invest in and provide the following resources and guidance to help you grow your career with confidence.

• Challenging and Dynamic Role
• Professional Growth Opportunities
• Performance Management and Coaching
• Specialized Training Programs
• Bar Exam/Bar Review Course Reimbursement

Michael Best & Friedrich LLPandMichael Best Strategies LLC,(collectively known as "Michael Best") are steadfastly committed to providing equal employment opportunity and maintaining a workplace for employees and applicants for employment that is free from discrimination based upon age, race, religion, color, disability, marital status,sex(including pregnancy), national origin, ancestry, ethnicity, sexual orientation, gender identity or expression, genetic information, veteran or military status, or any other status protected by applicable federal, state, or local law.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process please contact our Recruiting team at 414.225.4999 or [e-mail] to let us know the nature of your request
and your contact information.