Global Regulatory Affairs Strategy Lead

Regulatory Jobs; United States; Sur place; USD 155 000 - 190 000; Plein temps

Avantages offerts par ce poste

Health coverage

401(k) match

Tuition reimbursement

Wellness stipend

Bonus opportunities

Equity grants

Résumé du poste

Kailera Therapeutics, Inc. in the United States seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, coordinating INDs/CTAs and future marketing applications with cross-functional teams.

You will guide submissions, partner with Regulatory CMC and Operations, monitor global guidance, respond to authorities, and provide strategic regulatory insight to ensure compliant development programs.

Qualifications

• Knowledge of regulatory requirements in design and conduct of clinical trials.
• Understanding US and international regulatory guidelines and regulations.
• Experience with integrated drug development process and submissions.

Responsabilités

• Lead regulatory submission planning and strategy for IND/CTA and future marketing applications.
• Oversee compilation, review, and submission of regulatory documents to agencies.
• Monitor global regulatory guidance and communicate updates to stakeholders.

Connaissances

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Communication

Willingness to travel

Formation

Bachelor's degree + 10+ years in drug development

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

Description du poste

Kailera Therapeutics, Inc. in the United States seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, coordinating INDs/CTAs and future marketing applications with cross-functional teams.

You will guide submissions, partner with Regulatory CMC and Operations, monitor global guidance, respond to authorities, and provide strategic regulatory insight to ensure compliant development programs.