Associate Director, Global Regulatory Labeling and Ad Promo

Kailera Therapeutics•Waltham, MA

7d•Hybrid

About The Position

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. 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. Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Requirements

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

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