Global Labeling & Ad Promo Strategy Lead

Kailera Therapeutics; United States; On-site; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Equity grants

Annual bonus opportunities

Commuter benefits

Job summary

Kailera Therapeutics in the United States seeks an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling strategy and non-promotional activities. You will partner with cross-functional teams to ensure labeling reflects data and regulatory requirements throughout development, launch, and post-approval lifecycle.

Key responsibilities include maintaining US labeling, guiding regulatory strategy, and coordinating with MLR to ensure compliant communications.

Qualifications

• Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years.
• Regulatory guidelines knowledge (US and international) with focus on product labeling and advertising promotion.
• Deep knowledge of the integrated drug development process.
• Ability to find solutions and alternatives through teamwork resulting in positive business outcomes.
• Ability to assess and manage risk in a highly regulated environment.
• Strong written, spoken and presentation communication.
• Travel 10-15% expected.

Responsibilities

• Lead development, review, and maintenance of U.S. prescribing information, labeling, and promotional labeling.
• Provide regulatory guidance to ensure compliance with labeling regulations throughout development and lifecycle.
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams.
• Support labeling negotiations with FDA and manage approved labeling updates.
• Evaluate safety, efficacy, and scientific claims for consistency with labeling.
• Participate in MLR review process and coordinate with process owner.
• Ensure compliance with FDA regulations including FD&C Act and OPDP guidance.

Skills

Regulatory labeling

Cross-functional collaboration

FDA regulation knowledge

Risk management

Communication skills

Education

Bachelor’s degree in a relevant field

Advanced degree (PhD/PharmD/MS/MBA)

Job description

Kailera Therapeutics in the United States seeks an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling strategy and non-promotional activities. You will partner with cross-functional teams to ensure labeling reflects data and regulatory requirements throughout development, launch, and post-approval lifecycle.

Key responsibilities include maintaining US labeling, guiding regulatory strategy, and coordinating with MLR to ensure compliant communications.