Global Regulatory Labeling & Ad Promo Lead

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

Job summary

Kailera Therapeutics, Inc. in Waltham, MA is seeking an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling strategy and non-promotional communications.

This hub-based role is onsite 3–4 days per week and requires collaboration with clinical, CMC, medical, safety, and commercial teams. You will oversee US prescribing information, labeling, and promotional labeling, provide regulatory guidance for lifecycle management, support FDA negotiations, and ensure compliance with

Qualifications

• Advanced degree with 5+ years in drug development, including labeling.
• US and international regulatory guidelines knowledge, especially labeling.
• Experience with cross-functional teams and regulatory strategy.

Responsibilities

• Lead development, review, and maintenance of US labeling and promotional labeling.
• Provide regulatory guidance for labeling compliance across lifecycle.
• Collaborate with clinical, CMC, medical, safety, ops, and commercial teams.
• Support labeling negotiations with FDA and implement updates.
• Evaluate safety and efficacy claims for consistency with labeling.
• Participate in MLR process and regulatory governance.
• Monitor FDA Guidance and enforcement trends.
• Contribute to SOPs and governance.

Skills

Regulatory labeling

FDA regulations

Non-promotional labeling

Cross-functional teamwork

Risk assessment

Regulatory strategy

Communication

Travel

Education

Bachelor’s degree with 10+ years

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

Job description

Kailera Therapeutics, Inc. in Waltham, MA is seeking an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling strategy and non-promotional communications.

This hub-based role is onsite 3–4 days per week and requires collaboration with clinical, CMC, medical, safety, and commercial teams. You will oversee US prescribing information, labeling, and promotional labeling, provide regulatory guidance for lifecycle management, support FDA negotiations, and ensure compliance with