Associate Director, Global Regulatory Labeling and Ad Promo

Kailera Therapeutics; Boston (MA); On-site; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo to lead U.S. labeling strategy and non-promotional communications. This role partners with clinical, CMC, medical, safety, and commercial teams to ensure labeling reflects data and regulatory requirements.

The position requires advanced regulatory expertise, strong communication, and a willingness to travel (10–15%). Based in Waltham, MA with onsite presence 3–4 days per week.

Qualifications

• Lead U.S. labeling content and promotional labeling.
• Ensure regulatory compliance across lifecycle: development, registration, launch, post-approval.
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams.
• Support FDA labeling negotiations and implementation of updates.
• Evaluate safety, efficacy, and claims against approved labeling.
• MLR process involvement and coordination.
• Adhere to FDA regulations, OPDP guidance, PhRMA Code, and company policies.

Responsibilities

• Lead development, review, and maintenance of U.S. prescribing information and labeling.
• Provide regulatory guidance for labeling compliance across product lifecycle.
• Coordinate with cross-functional teams to reflect data and regulatory expectations in labeling.
• Negotiate with FDA and implement approved labeling changes.
• Assess claims for consistency with labeling and regulatory requirements.
• Participate in MLR reviews and governance processes.
• Monitor FDA guidance, enforcement actions, and industry practices on labeling and promotion.

Skills

Regulatory labeling

FDA regulations

Cross-functional teamwork

Regulatory strategy

Risk management

Education

Bachelor’s degree + 10+ years

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

Job description

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo to lead U.S. labeling strategy and non-promotional communications. This role partners with clinical, CMC, medical, safety, and commercial teams to ensure labeling reflects data and regulatory requirements.

The position requires advanced regulatory expertise, strong communication, and a willingness to travel (10–15%). Based in Waltham, MA with onsite presence 3–4 days per week.