Associate Director, Global Regulatory Labeling and Ad Promo

The role

The Associate Director, Global Regulatory Labeling and Ad Promo will be responsible for product labeling and non-promotional strategies. This person will work on cross-functional teams to maintain regulatory compliance.

What you will do

• Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary labeling, and promotional labeling
• Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams
• Support labeling negotiations with FDA and manage implementation of approved labeling updates
• Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
• Serve as a core member of the Medical, Legal, Regulatory (MLR) review process
• Ensure compliance with FDA regulations, FD&C Act requirements, FDA advertising and promotion regulations, OPDP guidance, and PhRMA Code requirements
• Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
• Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices
• Contribute to the development and maintenance of SOPs, policies, and governance processes

Required qualifications

• Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
• Established working knowledge of regulatory guidelines and regulations (US and international) with a focus on product labeling and advertising promotion
• Demonstrated deep knowledge of the integrated drug development process
• Demonstrated ability to find solutions and alternatives through teamwork
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Strong written, spoken and presentation communication
• Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.