- Attorney for Regulatory Counseling & Compliance
- In Legal Department
- Reports to Chief Legal Officer
- Full-time, Exempt Position
Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.
Provide regulatory counseling and litigation management regarding legal, policy, and regulatory matters for the Health, Emerging Companies and Agriculture & Environment groups at BIO. This advocacy counseling primarily involves any litigation and regulatory activities related to FDA, USDA, EPA and other agencies relevant to small business issues, as well as any related legislative and advocacy activities.
Also serve as in-house counsel providing legal services for the organization, including legal counsel (and at times supervising) compliance reports and matters, as well as training for BIO attorneys and staff.
- Provide legal counsel on advocacy and policy development at state and local, federal, and international legislative, regulatory, and trade-related matters for BIO on healthcare, agricultural, and environmental matters, including evaluating and developing comments on regulatory proposals, proposed legislation, and other legal documents;
- Serve as legal counsel to the Health, Emerging Companies, and Agriculture & Environment sectors at BIO for litigation management and support, antitrust counsel, corporate legal support, and advice and support on governance and compliance issues;
- Provide legal counsel, training and supervision (as needed) on compliance matters;
- Serve as counsel to section Boards as needed, as well as related staff-level committees, work streams and working groups;
- Provide legal assistance on voluntary industry self-regulatory initiatives (e.g., product stewardship and transparency) and communication campaigns related to section boards;
- Manage the efficient use of outside counsel within all of the above subject matters;
- Assist with other legal activities of the organization, as requested by the Chief Legal Officer (CLO)
Required Background, EDUCATION, and skills
- Excellent academic credentials, including J.D. degree.
- Admission in good standing to the District of Columbia (DC) bar or, alternatively, admission to the bar of another U.S. jurisdiction and ability to gain admission to the DC bar as needed.
- At least five (5) years of relevant legal experience required, preferably including, or in addition to, experience in a trade association, member company, government regulatory agency, or similar organization.
- Experience interacting with Boards of Directors and senior executives strongly preferred.
- Knowledge of federal and state ethics and lobbying rules.
- Ability to write reports, legal memoranda, business correspondence, and procedure manuals.
- 10 + years of experience preferred
- Some travel required
- Knowledge of trade association-specific law (including antitrust and consumer protection), as well as contracts, compliance, and general legislative and regulatory advocacy laws.
- Knowledge of state and federal regulatory/legislative processes, including administrative law principles and procedures, and experience with litigation involving government entities.
- Knowledge of the regulatory and legal framework for healthcare, agricultural biotechnology, industrial and environmental biotechnology (including renewable fuels, bio-based products, and/or bio-based chemicals), and for small business issues (e.g. capital formation, tax, securities, etc.).
- Knowledge of the biotechnology industry strongly preferred.
- Excellent oral and written communication skills, including the ability to communicate effectively and accurately with other BIO staff, member companies, Board Directors, regulatory agency personnel, and internal and external counsel for other entities and organizations.
- Strong inter-personal skills, and the ability to build consensus and foster compromise among sometimes competing interests.
- The ability to work efficiently under tight deadlines.
Candidates should be aware that BIO currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date BIO is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.