AbbVie
Associate General Counsel - R&D Innovation Legal (Regulatory)
AbbVie, Irvine, California, United States, 92713
Associate General Counsel - R&D Innovation Legal (Regulatory)
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Associate General Counsel - R&D Innovation Legal (Regulatory)
role at
AbbVie
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This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $177,000.00/yr - $336,000.00/yr
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 at www.abbvie.com.
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.
Provide 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 Doctorate and 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.
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 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.
Hybrid work location: must be located proximate to North Chicago, IL or in the Washington, DC metro area.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal, Management, and Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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, visit https://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
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Associate General Counsel - R&D Innovation Legal (Regulatory)
role at
AbbVie
Get AI-powered advice on this job and more exclusive features.
This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $177,000.00/yr - $336,000.00/yr
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 at www.abbvie.com.
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.
Provide 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 Doctorate and 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.
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 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.
Hybrid work location: must be located proximate to North Chicago, IL or in the Washington, DC metro area.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal, Management, and Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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, visit https://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
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