Global Regulatory Affairs Lead — IND/CTA Strategy

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

Benefits offered by this job

Health insurance

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus

Job summary

Kailera Therapeutics, Inc. in Massachusetts is seeking an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early/late phase products, writing and submitting IND/CTA amendments and future marketing applications, and guiding teams on filings.

You will partner with Regulatory CMC and Regulatory Operations, provide regulatory intelligence, stay updated on global guidance, and respond to agency questions, with 10–15% travel.

Qualifications

• Knowledge of regulatory requirements in design and conduct of clinical trials and submissions.
• Working knowledge of US and international regulatory guidelines and regulations.
• Deep knowledge of the integrated drug development process.
• Ability to find solutions through teamwork and manage risk in a highly regulated environment.
• Strong written, spoken, and presentation communication.

Responsibilities

• Serve as regulatory representative on core teams, developing submission strategies and coordinating regulatory submissions.
• Oversee compilation, review, and submission of regulatory applications to agencies with accuracy and timeliness.
• Monitor regulatory environment and communicate developments to stakeholders.
• Stay updated on global regulatory guidance and communicate key updates to leadership and project teams.
• Respond to regulatory questions from authorities in collaboration with subject matter experts.
• Provide strategic regulatory guidance for global development and registration programs (INDs, CTAs, NDAs, MAAs).
• Assess and communicate regulatory requirements to ensure development activities follow regulations and guidelines.
• Contribute to SOPs and internal work instructions.

Skills

Regulatory submissions

IND/CTA experience

Global regulatory

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's degree + 10+ years in drug development

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

Job description

Kailera Therapeutics, Inc. in Massachusetts is seeking an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early/late phase products, writing and submitting IND/CTA amendments and future marketing applications, and guiding teams on filings.

You will partner with Regulatory CMC and Regulatory Operations, provide regulatory intelligence, stay updated on global guidance, and respond to agency questions, with 10–15% travel.