Senior R&D Regulatory Counsel – Life Sciences

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in North Chicago, IL is seeking an Associate General Counsel for the R&D Innovation Legal group to guide the development of new medicines. You will provide strategic counsel on complex regulatory and legal issues shaping our long-term pipeline and strategic decisions, working closely with senior leaders.

The role requires a J.D. and 10+ years in life sciences law with deep FDA regulatory and drug development expertise.

Qualifications

• J.D. and bar admitted in at least one U.S. state.
• Minimum 10+ years in life sciences law or related roles.
• Expertise in FDA regulations and drug development, including exclusivities, orphan designations, clinical trial design and data requirements.
• Experience with interactions with government health authorities desirable.
• Familiarity with Inflation Reduction Act, Most Favored Nation and CMS policies.
• Ability to work independently and lead cross-functional teams.
• Excellent oral and written communication; able to present to senior leaders.
• Ability to be in the office 3 days/week in North Chicago, IL or the Washington, DC metro area.

Responsibilities

• Develop strategic counsel to senior leaders on legal regulatory issues impacting pipeline development.
• Advises R&D organization; not FDA promotional or Commercial.
• Support Regulatory Affairs on regulatory filings and agency engagements.
• Learn Inflation Reduction Act and MFN policies to guide R&D decisions.
• Educate AbbVie legal and business stakeholders on emerging laws and industry trends.
• Identify complex legal issues and propose creative resolutions.
• Advise executives on outcomes and optimize results for the company.
• Collaborate with cross-functional teams and present findings to senior leaders.

Skills

FDA regulatory experience

Drug development experience

Regulatory strategy

Cross-functional leadership

Communication skills

Education

J.D. and bar admission in at least one U.S. state

Job description

AbbVie in North Chicago, IL is seeking an Associate General Counsel for the R&D Innovation Legal group to guide the development of new medicines. You will provide strategic counsel on complex regulatory and legal issues shaping our long-term pipeline and strategic decisions, working closely with senior leaders.

The role requires a J.D. and 10+ years in life sciences law with deep FDA regulatory and drug development expertise.