Global Regulatory Affairs Lead - IND/CTA Submissions

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

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, guiding IND/CTA submissions and future marketing applications, and advising cross-functional teams on regulatory filings.

The role collaborates with Regulatory CMC and Regulatory Operations to ensure scientific data and submissions meet agency expectations in a compliant manner. Onsite in Waltham, MA, 3–4 days a week.

Qualifications

• Knowledge of US and international regulatory requirements for clinical development
• Experience with IND/CTA submissions and regulatory strategies
• Ability to lead cross-functional teams and manage timelines
• Strong written, spoken, and presentation communication
• Willingness to travel (10–15%)

Responsibilities

• Serve as regulatory lead on core teams, plan regulatory submission strategies
• Coordinate preparation and submission of regulatory applications to agencies
• Monitor regulatory developments and communicate updates to stakeholders
• Provide strategic regulatory guidance for global development programs (INDs/CTAs/NDAs/MAAs)
• Ensure compliance with applicable regulations and guidelines across development activities

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Leadership

Attention to detail

Communication skills

Travel readiness

Education

Bachelor's degree in life sciences or related field

Advanced degree (PhD/PharmD/MS/MBA)

Tools

Regulatory intelligence tools

Job description

Kailera Therapeutics seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, guiding IND/CTA submissions and future marketing applications, and advising cross-functional teams on regulatory filings.

The role collaborates with Regulatory CMC and Regulatory Operations to ensure scientific data and submissions meet agency expectations in a compliant manner. Onsite in Waltham, MA, 3–4 days a week.