Global Regulatory Affairs Director, Submissions & Strategy

Kailera Therapeutics, Inc.; Northern (KY); Hybrid; USD 155,000 - 190,000; Full time

Benefits offered by this job

Comprehensive health coverage

401(k) with match

Tuition reimbursement

Annual bonus opportunities

Equity grants

Commuter benefits

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director of Global Regulatory Affairs to lead day-to-day regulatory activities for investigational products and future marketing submissions.

You will guide teams on IND/CTA filings, provide regulatory intelligence, and ensure compliance across global development programs. The role requires deep regulatory expertise, cross-functional collaboration, and willingness to travel (10–15%).

Qualifications

• Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials and regulatory submissions.
• Experience with US and international regulatory guidelines and drug development processes.
• Ability to guide cross-functional teams through IND/CTA, NDA/MAA submissions and responses.

Responsibilities

• Serve as regulatory lead on core teams, planning submission strategies and coordinating regulatory filings.
• Oversee compilation and submission of regulatory applications to agencies with accuracy and timeliness.
• Monitor global regulatory developments and communicate updates to leadership and project teams.
• Provide strategic regulatory guidance for global development programs and filings.

Skills

Regulatory strategy

Global regulatory submissions

Cross-functional collaboration

Regulatory risk management

Strong communication

Travel willingness

Education

Bachelor's degree + 10+ years experience

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

Job description

Kailera Therapeutics, Inc. is seeking an Associate Director of Global Regulatory Affairs to lead day-to-day regulatory activities for investigational products and future marketing submissions.

You will guide teams on IND/CTA filings, provide regulatory intelligence, and ensure compliance across global development programs. The role requires deep regulatory expertise, cross-functional collaboration, and willingness to travel (10–15%).