Food & Drug Law Attorney in North Chicago, IL

In-House

North Chicago, IL

Food & Drug Law Attorney in North Chicago, IL

Attorney

10-12 yrs required

No

Job Title: Associate General Counsel - R&D Innovation Legal, Regulatory

Job Responsibilities:
- Develop and provide strategic counsel to senior leaders within the Legal and Regulatory Strategy organizations on legal regulatory issues that impact pipeline development and product innovation. This role focuses on advising the R&D organization and does not involve FDA promotional considerations.
- Provide legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting investigational and on-market drug products.
- Educate other legal departments and business stakeholders on emerging laws, regulations, and industry trends impacting the company's portfolio.
- Proactively identify highly complex legal issues related to assigned matters, develop creative and alternative solutions, and implement resolutions.
- Adopt a business-oriented and creative approach to problem-solving.
- Identify unmet needs and future legal issues and proactively propose strategies to optimize outcomes and results for the company.
- Advise Vice Presidents, Presidents, and Officers, being recognized by these clients as an expert in the substantive area and relied upon for individual advice.

Education and Experience Information:
- Juris Doctorate and currently admitted to the bar in at least one . state.
- Minimum of 10+ years (12+ preferred) of relevant experience practicing as a member of a nationally recognized law firm in a life sciences practice, practicing in-house at a pharmaceutical company, or practicing as an attorney for the FDA, or any combination of the above.
- Substantial expertise in FDA regulations and guidance around innovator drug development, including clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products, with familiarity with policies to advance innovation in the industry.
- Experience working for or having interactions with government health authorities is highly desirable.
- Familiarity with the Inflation Reduction Act and its impact on drug development strategies is a plus.
- Knowledge and understanding of pharmaceutical laws and regulations to help business clients assess issues in a highly regulated landscape.
- Demonstrated ability to work independently and lead cross-functional teams collaboratively.
- Ability to adapt to a changing environment while handling multiple priorities.
- Excellent oral and written communication skills, comfortable presenting complicated information accurately and concisely to senior leaders.
- The role requires the individual to be located proximately to North Chicago, IL, or in the Washington, DC metro area as this is a hybrid opportunity.

Salary Information:
- The compensation range for this role is $177,000 - $336,000. The actual pay will depend on many factors, including geographic location, and the company may ultimately pay more or less than the posted range. This range may be modified in the future.
- The company offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- The job is eligible to participate in short-term and long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remain in the company's sole and absolute discretion unless and until paid and may be modified at the company’s sole and absolute discretion, consistent with applicable law.

Company is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving the community. Equal Opportunity Employer/Veterans/Disabled.