- Location
- Waltham, Massachusetts
- Workplace
- Onsite
- Department
- Regulatory
- Seniority
- Entry
- Experience
- 5+ years
- Education
- PhD
- Source
- Greenhouse
Description
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.
Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
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
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. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
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.
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