Senior Global Regulatory Counsel

BioSpace; Indianapolis (IN); Remoto; USD 230.000 - 337.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Retirement plan (401(k)/pension)

Health, dental, vision coverage

Flexible spending accounts

Life insurance

Vacation benefits

Well-being programs

Employee resource groups (ERGs)

Descrizione del lavoro

Lilly is seeking an Associate Vice President, Assistant General Counsel, Global Regulatory Legal to provide strategic regulatory counsel across the full lifecycle of pharmaceutical and medical device products. This role will influence regulatory strategy and ensure alignment with global authorities.

The position may be based at Lilly’s Indianapolis headquarters or performed remotely, with 10–15% travel. Strong leadership, collaboration, and communication skills are essential.

Competenze

• JD required and bar admission in at least one US jurisdiction.
• Broad regulatory law expertise across product lifecycle.
• Ability to manage a substantial regulatory portfolio independently.
• Strong written and verbal communication for leadership.
• Experience navigating FDA/global health authorities is highly preferred.

Mansioni

• Provide strategic, solutions-oriented regulatory counsel across drugs, devices, and diagnostics.
• Advise Global Regulatory Affairs throughout the product lifecycle from registration to post‑market risk management.
• Lead FDA regulatory engagement strategy, including pre-submission meetings and information requests.
• Support regulatory submissions to global health authorities as needed.
• Advise on regulatory strategy for M&A, in-licensing, and asset transfers with due diligence.
• Integrate regulatory, litigation, and enforcement risk perspectives for leadership.
• Represent Lilly in industry forums and coordinate responses to regulatory inquiries.

Conoscenze

Regulatory law expertise

Strategic counsel

Cross-functional collaboration

Client management

Communication excellence

Formazione

Juris Doctor

US bar admission

Descrizione del lavoro

Lilly is seeking an Associate Vice President, Assistant General Counsel, Global Regulatory Legal to provide strategic regulatory counsel across the full lifecycle of pharmaceutical and medical device products. This role will influence regulatory strategy and ensure alignment with global authorities.

The position may be based at Lilly’s Indianapolis headquarters or performed remotely, with 10–15% travel. Strong leadership, collaboration, and communication skills are essential.