Global Regulatory Counsel, AVP — Life Sciences (Remote)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 230,000 - 337,000; Full time

Job summary

Lilly in Indianapolis, Indiana, seeks an Associate Vice President, Assistant General Counsel – Global Regulatory Legal. This senior regulatory attorney partners with the Regulatory Legal Team to guide product development through post‑market activities, ensuring compliance across diverse global authorities.

The role requires deep regulatory expertise, a strategic mindset, and the ability to influence a matrixed organization. Travel is possible; remote options are acceptable.

Qualifications

• Juris Doctor degree and bar license in at least one US jurisdiction.
• 10+ years of experience in pharmaceutical regulatory law (law firm or in-house).
• Broad regulatory expertise spanning the product lifecycle.
• Ability to manage a substantive and complex regulatory portfolio independently.
• Strong judgment and collaboration across functions and leadership.

Responsibilities

• Advise Global Regulatory Affairs with strategic, forward‑looking guidance across the lifecycle.
• Shape FDA engagement strategy, including pre‑submissions and information requests.
• Oversee regulatory due diligence for acquisitions, in-licensing, and asset transfers.
• Integrate regulatory, litigation, and enforcement risk perspectives with BU Legal, IP, and other teams.
• Monitor evolving global regulatory laws and translate developments into leadership guidance.
• Represent Lilly in regulatory policy initiatives and coordinate regulatory responses.

Skills

Regulatory law

Strategic counsel

Regulatory strategy

Cross-functional collaboration

Written and verbal communication

Education

Juris Doctor (JD)

Job description

Lilly in Indianapolis, Indiana, seeks an Associate Vice President, Assistant General Counsel – Global Regulatory Legal. This senior regulatory attorney partners with the Regulatory Legal Team to guide product development through post‑market activities, ensuring compliance across diverse global authorities.

The role requires deep regulatory expertise, a strategic mindset, and the ability to influence a matrixed organization. Travel is possible; remote options are acceptable.