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

Alaska Department of Law; Falls Church (VA); Hybrid; USD 177,000 - 336,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks an Associate General Counsel to navigate complex regulatory landscapes while supporting the R&D organization. The successful candidate will advise on critical legal issues affecting pipeline development and product innovation, requiring a Juris Doctorate and significant experience in life sciences law.

Benefits

Comprehensive benefits package including medical, dental, vision.

401(k) plan for eligible employees.

Participation in short-term and long-term incentive programs.

Qualifications

• Minimum of 10+ years of relevant experience practicing law.
• In-depth knowledge of pharmaceutical laws and FDA regulations.
• Experience working with government health authorities.

Responsibilities

• Provide strategic legal counsel on regulatory issues impacting product innovation.
• Support Regulatory Affairs with critical regulatory filings and agency engagements.
• Educate stakeholders on emerging laws and trends.

Skills

Expertise in FDA regulations

Excellent oral and written communication

Problem solving and strategic thinking

Ability to work independently

Education

Juris Doctorate

Job description

ICompany 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. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik 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 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.
• 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 or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $177,000 - $336,000
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our 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 remains 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.

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.htmlI