Associate Director, Global Regulatory Labeling and Ad Promo

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

Benefits offered by this job

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

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director, Global Regulatory Labeling and Ad Promo to lead labeling strategies and non-promotional communications for US products.

You will work cross-functionally to ensure regulatory compliance across development, launch and post-approval phases. The role focuses on developing, reviewing and maintaining labeling content, collaborating with clinical, CMC, medical, safety, and commercial teams, and guiding FDA interactions while upholding high

Qualifications

• Advanced degree with at least 5 years of drug development experience including product labeling or a bachelor’s with 10+ years
• Established working knowledge of US and international regulatory guidelines focusing on labeling and advertising promotion
• Demonstrated deep knowledge of the integrated drug development process
• Ability to collaborate in cross-functional teams to drive regulatory solutions

Responsibilities

• Lead development, review, and maintenance of U.S. prescribing information and labeling
• Provide regulatory guidance to ensure compliance with labeling requirements throughout development, launch and post-approval
• Collaborate with clinical, CMC, medical, safety, device engineering, operations and commercial teams on labeling content
• Support labeling negotiations with FDA and manage implementation of approved labeling updates
• Evaluate safety, efficacy and scientific claims for consistency with approved labeling
• Serve on the MLR review process and align with the process owner
• Ensure compliance with FDA regulations including FD&C Act, advertising rules, OPDP guidance and PhRMA Code

Skills

Regulatory labeling

FDA regulations

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree with 10+ years

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

Job description

Associate Director, Global Regulatory Labeling and Ad Promo

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members.

Responsibilities:

• Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) 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 to ensure labeling content accurately reflects available data and regulatory requirements


• 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. Collaborate with MLR process owner


• Ensure compliance with FDA regulations, including:
  
  
  
  • FD&C Act requirements
  
  
  • FDA advertising and promotion regulations
  
  
  • OPDP guidance and enforcement trends
  
  
  • PhRMA Code requirements
  
  
  • Company policies and procedures
  
  
  
  


• 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 related to labeling and promotional review


• 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 particular 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 resulting in positive business outcomes


• 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


• Travel expected (10-15%)

Education:

• Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience

Salary Range

$155,000 - $190,000 USD

For Full Time Roles:

This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

• 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

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

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