Global Regulatory Strategy Lead

Kailera Therapeutics; United States; On-site; USD 155,000 - 190,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Wellness stipend

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics is a forward‑looking biopharma seeking an Associate Director, Global Regulatory Affairs to lead day‑to‑day regulatory activities for early and late‑phase programs, including IND/CTA submissions and future marketing applications.

The role partners with Regulatory CMC and Regulatory Operations to ensure scientifically robust submissions and timely agency responses, guiding global development programs with strategic regulatory insight.

Qualifications

• Experience in design and conduct of clinical trials and preparation of regulatory submissions
• Working knowledge of US and international regulatory guidelines and regulations
• Understanding of integrated drug development process
• Ability to solve problems through teamwork and drive business outcomes
• Ability to assess and manage risk in a highly regulated environment
• Strong written, spoken, and presentation communication
• Willingness to travel 10–15%

Responsibilities

• Lead regulatory submission strategies for core programs and coordinate IND/CTA submissions
• Oversee compilation, review, and submission of regulatory applications to agencies
• Monitor regulatory developments and communicate impacts to stakeholders
• Provide regulatory guidance for global development and registration programs
• Respond to regulatory questions from authorities with clinical development and safety input
• Develop internal SOPs and work instructions related to regulatory affairs
• Ensure compliance with applicable regulations and guidelines

Skills

Regulatory submissions

Global regulatory strategy

Clinical development knowledge

Regulatory intelligence

Cross-functional collaboration

Regulatory risk management

Communication skills

Travel availability

Education

Bachelor's degree in life sciences or related field

Advanced degree (PhD/PharmD/MS/MBA)

Job description

Kailera Therapeutics is a forward‑looking biopharma seeking an Associate Director, Global Regulatory Affairs to lead day‑to‑day regulatory activities for early and late‑phase programs, including IND/CTA submissions and future marketing applications.

The role partners with Regulatory CMC and Regulatory Operations to ensure scientifically robust submissions and timely agency responses, guiding global development programs with strategic regulatory insight.