Associate General Counsel - R&D Innovation Legal (Regulatory)

Internal Revenue Service; Washington (District of Columbia); Hybrid; USD 177,000 - 336,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Associate General Counsel for its R&D Innovation Legal group. The ideal candidate will guide the organization through the legal landscape of drug development, requiring extensive experience and a commitment to innovative solutions in a highly regulated sector. This hybrid role offers the opportunity to influence pipeline strategies significantly.

Benefits

Comprehensive benefits package including paid time off

401(k) plan eligibility

Participation in short-term and long-term incentive programs

Qualifications

• 10+ years legal experience, preferably in life sciences or FDA-related.
• Expertise in pharmaceutical laws and regulations.
• Proven ability to work independently and lead teams.

Responsibilities

• Provide strategic counsel on legal and regulatory issues for R&D.
• Support regulatory filings and engage with government health authorities.
• Educate stakeholders on emerging laws and industry trends.

Skills

Communication

Regulatory Expertise

Creative Problem Solving

Education

Juris Doctorate

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbVie’s R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. This individual will be motivated by the opportunity to address and solve emerging issues with a strategic and creative business-oriented approach and provide expert counsel on decisions impacting our long-term pipeline strategies.

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. Assigned matters have significant impact to AbbVie overall. This is a role advising the R&D organization and not on FDA promotional considerations.
• Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements relating to R&D issues impacting our investigational and on-market drug products.
• Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and industry trends impacting AbbVie portfolio.
• Proactively identifies highly complex legal issues related to assigned matters, develops creative and alternative solutions, and implements resolution.
• Adopts a business oriented and creative approach to problem solving.
• Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company.
• Advises Vice Presidents, Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice.

Qualifications

• Juris Doctorateand currently admitted to the bar in at least one U.S. 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.
• Individual will have substantial expertise in FDA regulations and guidance around innovator drug development, including on clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products, and have 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 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.
• To enable success in the role, an individual must be located proximately to North Chicago, IL or in the Washington, DC metro area as this is a hybrid opportunity.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.Salary: $177,000 - $336,000

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.

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

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html