Associate Director – Global Regulatory Affairs, Product Communications

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide direction and influence to ensure precise, well-balanced, and substantiated communications regarding products and diseases for designated assets.

• Collaborate with Regulatory Scientists, Lilly brand teams, partner organizations, and the FDA Office of Prescription Drug Promotion (OPDP) to offer guidance on regulatory requirements and expectations.

• Act as the Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications.

• Evaluate promotional strategies, internal communications for field teams, medical affairs communications, campaign initiatives, press materials, and communications for investor relations.

• Offer timely and definitive regulatory guidance to facilitate informed business decisions.

• Convey regulatory expectations based on OPDP feedback, relevant laws, regulations, guidelines, and FDA enforcement actions.

• Contribute to strategies for mitigating business risks by monitoring trends in advertising, promotion, and medical communications.

• Foster and sustain relationships with Lilly colleagues and partner organizations.

• Initiate plans for discontinuing promotional tactics in response to Regulatory-triggered events.

• Advise internal partners on OPDP advisory strategies and collaborate on promotional proposals and submission documents.

• Work alongside US brand teams to interpret OPDP advice and facilitate interactions with OPDP.

• Review Form 2253 submissions of promotional materials to the FDA.

• Involve US Regulatory Scientists in discussions regarding promotional claims, marketing strategies, press materials, and communications for investor relations.

• Lead revisions of labeling in collaboration with US Regulatory Scientists and Labeling Operations.

• Share critical information to support the execution of US regulatory strategies and promotional activities.

• Participate in forums that disseminate regulatory information throughout the organization and among business partners.

• Constructively challenge teams and guide open discussions to ensure robust business decisions.

⛳️ Requirements

• Bachelor's Degree.

• A minimum of 3 years of industry-related experience in drug development and/or commercialization.

• Authorized to work full-time in the United States.

• Lilly will not provide sponsorship or support for work authorization or visas for this position.

• Familiarity with FDA procedures and practices, including CFR guidelines and guidance documents.

• Ability to influence without direct authority and manage complex projects within set timelines.

• Excellent communication skills, encompassing active listening, verbal, and written communication.

• Capacity to apply systematic thinking to business challenges and opportunities.

• Effective teamwork abilities and adaptability to diverse interpersonal styles.

• Recent experience in reviewing advertising and promotional materials for prescription drug products.

• Awareness of ongoing regulatory reform initiatives and forthcoming changes.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.