Global Labeling & Ad Promo - Associate Director

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

Job summary

Kailera Therapeutics, Inc. in the United States seeks an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling activities and ensure regulatory compliance across product lifecycle.

You will partner with clinical, CMC, medical, safety, and commercial teams to align labeling with available data and regulatory requirements. This role requires advanced degree with 5+ years in drug development or a bachelor’s with 10+ years.

Qualifications

• Advanced degree or equivalent with extensive experience in product labeling and advertising promotion.
• Strong knowledge of US and international regulatory guidelines and FDA requirements.
• Ability to partner with cross-functional teams and lead labeling initiatives.
• Experience managing MLR reviews and regulatory submissions.

Responsibilities

• Lead development, review, and maintenance of U.S. prescribing information and labeling.
• Provide regulatory guidance to ensure compliance across product lifecycle.
• Collaborate with clinical, CMC, medical, safety, and commercial teams.
• Support labeling negotiations with FDA and implement approved updates.
• Evaluate safety, efficacy, and claims for consistency with labeling.
• Serve as core member of MLR review process.
• Monitor FDA guidance, enforcement actions, and industry practices.
• Contribute to SOPs, policies, and governance.

Skills

Regulatory labeling

FDA advertising/promo regulations

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree with 10+ years

Advanced degree (PhD/PharmD/MS/MBA) with 5+ years

Job description

Kailera Therapeutics, Inc. in the United States seeks an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling activities and ensure regulatory compliance across product lifecycle.

You will partner with clinical, CMC, medical, safety, and commercial teams to align labeling with available data and regulatory requirements. This role requires advanced degree with 5+ years in drug development or a bachelor’s with 10+ years.