Global Regulatory Labeling & Ad Promo Lead (Hybrid)

Kailera Therapeutics; Waltham (MA); On-site; USD 155,000 - 190,000; Full time

Job summary

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo in Waltham, MA to lead labeling strategy and cross-functional regulatory activities. This role focuses on U.S. labeling development, FDA interactions, and ensuring regulatory compliance across product lifecycle.

Requires advanced degree with 5+ years in drug labeling or a 10+ year bachelor pathway; travel 10-15% anticipated. Compensation includes strong health coverage and bonus potential.

Qualifications

• Advanced degree with 5+ years of drug development experience including product labeling, or a Bachelor's with 10+ years.

Responsibilities

• Lead development, review, and maintenance of U.S. prescribing information, patient labeling, and promotional labeling.
• Provide regulatory guidance to ensure compliance with labeling regulations across development, registration, launch, and post-approval lifecycle.
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content reflects data and regulatory requirements.
• Support labeling negotiations with FDA and manage approved labeling updates.
• Evaluate safety, efficacy, and scientific claims for consistency with approved labeling.
• Serve as core member of the MLR review process and collaborate with the process owner.
• Ensure compliance with FDA regulations, including FD&C Act, advertising/promotions, OPDP, PhRMA Code, and company policies.
• Provide regulatory recommendations to support compliant non-promotional and promotional communications.
• Monitor evolving FDA guidance and enforcement related to labeling and promotional review.
• Contribute to development and maintenance of SOPs, policies, and governance processes

Skills

Regulatory labeling

FDA regulations

Cross-functional

Strategic thinking

Regulatory strategy

Education

Advanced degree (PhD/PharmD/MS/MBA)

Bachelor’s with 10+ years

Tools

Regulatory databases

Job description

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo in Waltham, MA to lead labeling strategy and cross-functional regulatory activities. This role focuses on U.S. labeling development, FDA interactions, and ensuring regulatory compliance across product lifecycle.

Requires advanced degree with 5+ years in drug labeling or a 10+ year bachelor pathway; travel 10-15% anticipated. Compensation includes strong health coverage and bonus potential.