Description:
The Role:We are seeking a highly self-motivated and detail-oriented attorney whose full gamut experience in legal, regulatory and cross functional global business has made you a leader in your field. The ideal candidate has experience in product compliance and interfacing with U.S. authorities, such as the FDA and the FTC and has a mix of experience ranging from overseeing day to day legal in a hyper growth company, to leading complex advocacy issues. You will have a track record of successfully fighting for controversial innovation. Through your previous battles you have learned how to rapidly and safely grow a business in a highly innovative and regulated space while creating and maintaining sustainable competitive advantage. You have come to understand the relationship between high risk and high reward and find ways to navigate the thin line of compliance and advantage while always landing on the right side. You also have a driven nature and can do demeanor where 'I can't' isn't a term in your vocabulary because you are creative in solving difficult challenges, while minimizing risk and maximizing compliance.
You will be a key member of the leadership team and will also participate in securing high profile executives and advisors, customers, and financial backers from banks, to underwriters, to strategic investment partners. You will lead our aggressive outbound litigation practice protecting assets, brand, and competitive advantage in all elements of the businesses. You will also lead all forms of liability mitigation, including foundational work protecting against inbound federal, state or customer-oriented litigation. Working with and through external counsel, you will be the key point of contact for all regulatory agencies.
In summary: this position will lay the groundwork for our category ? being a right hand in advancements with federal and state legislation, navigating relationships with regulators, securing key partnerships from key customers, distributors, and underwriters, ultimately steering how we grow in a way that's safe, but innovative, while maximizing short-, medium- and long-term value. This role will report to our visionary and very driven CEO in a team oriented, fast paced, scrappy, and high growth/high profit business.
Core Responsibilities:
- Review and approve product claims, substantiation, labeling/packaging, advertising (including social and digital executions), promotional materials, consumer responses, and other external communications;
- Provide cross-functional leadership and support involving R&D, regulatory, quality, sales, and marketing department;
- Support outside counsel in offensive and defensive claims and litigation and in proceedings before National Advertising Division, government regulatory bodies (including FDA and FTC);
- Supervise US and international outside counsel, primarily on regulatory and advertising matters;
- Lead interface with U.S. authorities (including but not limited to FDA) and Canadian authorities (including but not limited to Health Canada);
- Support product recall issues in the U.S. and Canada;
- Independently handle all regulatory authority inquiries;
- Independent and continuous analysis, monitoring, and evaluation of relevant legal regulations in the U.S. and foreign, including current developments at legislative levels;
- Independent legal evaluation of actual and potential risks and liabilities, as well as the development of methods, processes, procedures, and systems to ensure compliance;
- Independent preparation of general legal and business guidelines and legal expert opinions, taking into account current legal developments and legislative developments (actual and anticipated);
- Provide pragmatic day-to-day advice, together with strategic advice to minimize legal risks and liabilities while advancing business goals and initiatives;
- Counsel and train employees on relevant regulatory compliance issues, best practices, and corporate strategies;
- Develop and organize training courses to ensure legal and product compliance, best practices, and corporate strategies;
- Provide expert and strategic legal advice to management in complex matters with significant risk potential;
- Anticipate product compliance issues and opportunities; assess risks, evaluate, and weigh multiple business and regulatory inputs and impacts of possible decisions or outcomes to propose appropriate mitigating and/or facilitating courses of action;
- Manage filings and pending regulatory/compliance FDA/DOJ claims, managing battle plans, PR, and other aspects of litigation;
- Create internal regulatory/compliance guidelines for future new product development;
- Provide oversight and leadership of the Federal and state lobby team and the creation and operation of various third-party organizations to advocate for our interests;
- In collaboration with sales, engage with key retail customers and distribution partners to secure their confidence, minimize their risk, and acquire their business;
- In collaboration with finance, develop capital acquisition and exit strategy and advocate with all stakeholders to successfully advance high value exit;
- Create a portfolio-wide legal database where all documents are tracked, organized, and updated to reflect ongoing efforts and strategy;
- Organize all legal needs of company in a detailed, dynamic, and highly responsive model; and
- Drive the founder's vision to execution.
Requirements:
- Bachelor's degree and a Juris Doctorate degree from a U.S. accredited law school; MBA preferred.
- Licensed to practice law in at least one U.S. or Canadian jurisdiction.
- 8-10+ years of experience as a licensed attorney for a law firm or in-house corporate counsel
- FDA compliance and regulated products industry experience (OTC drugs, homeopathic, or dietary supplements).
- A powerful network for US focused regulatory and political success
- A background in science and experience with its use to defend and attack in the process of opening and securing value in a category.
- Extensive experiences with various regulatory agencies in fields such as supplements, pharmaceuticals, cannabis and/or alcohol.
- Previous experience in managing/leading state and federal lobbying to successfully stop and advance strategic legislation including mobilization of public affairs initiatives as required.
- Diverse and extensive inbound and outbound litigation experience including, state, state federal, trademark and consumer liability.
- Previous successful experience working with highly driven entrepreneurial founders and CEO's.
- Ability to work autonomously, taking accountability without a huge team behind them.
- Ability to identify, evaluate and provide risk-appropriate solutions to the business based on excellent legal and business judgment.
- Proven ability to succinctly and cogently articulate positions and to draft contracts in clear, concise language.
- Strong written and verbal communication skills.
- Effective organizational skills and the ability to manage multiple projects simultaneously and complete them on time.
- Be a team player who can perform assigned responsibilities with a great level of independence and ownership.
- Experience working in a cross-department, cross-functional role requiring good relationship building skills.
- Highly detailed and organized communication style, including the ability to advantage in highly charged fast moving environments.
- You are technologically savvy, quick with tools e.g., O365, G-suite, and great at building visual reports and decision trees.
- Willingness and ability to work the hours it takes to be successful.
Who You Are:
- Visionary - You see the future and you create it. In your highly connected and highly trusted relationships with all stakeholders, you are a credible and informed beacon for opportunity and possibility. Where others see impossibility, you see massive opportunity, and can articulate it in a highly credible and compelling way.
- Leader - You have a natural style of leadership that attracts highly talented people and inspires them to find, hold and conquer mountains, as a team. You have a group of people that follow you to where you go, are a great judge of talent, and are a strong force for creating an unstoppable winning culture.
- Relentless - You have deep internal motivation to win and have a clear track record of perseverance and accomplishment under difficult circumstances. You are at a place in your life where you are prepared to dedicate yourself to your work and you are ready to build something meaningful on a global scale.
- Organized - In a world of risks everywhere, you bring a highly organized and detail-oriented approach to all your work that allows you to be precise yet expedient in a fast growth, high stakes environment that is constantly changing. You can manage a wide variety of projects, contracts, conversations, issues, and risks in a manner that clearly demonstrates competence.
- Strategic - Where others are stuck in checkers, you play a strong game of chess. Whether it is an agreement with a business partner or a federal bill, you think many moves ahead. You can factor many variables in complex situations and know how to apply powerful tools such as public opinion, lobbying, key relationships, litigation, financials analysis, and highly engaged strategic partners to make the impossible possible.
- Motivated - You are at a place
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