Associate Director, Global Regulatory Affairs & Submissions

Regulatory Jobs; United States; Híbrido; USD 155 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus opportunities

Equity grants

Resumo da oferta

Kailera Therapeutics, Inc. seeks an Associate Director of Global Regulatory Affairs to lead day-to-day regulatory activities for early/late phase investigational products.

You will direct IND/CTA submissions, guide regulatory filings, and provide regulatory intelligence across global programs, collaborating with CMC, Regulatory Operations, and cross-functional teams. The role emphasizes strategic regulatory leadership, risk management, and ensuring compliance with agency expectations while

Qualificações

• Knowledge of regulatory submissions for IND/CTA and filings
• Experience with global regulatory guidelines (US and international)
• Strong writing, communication, and presentation skills
• Travel expected (10–15%)

Responsabilidades

• Serve as regulatory representative on core teams and plan submission strategies
• Oversee preparation and submission of regulatory applications to agencies
• Monitor regulatory developments and advise stakeholders
• Provide strategic regulatory guidance for global development programs (INDs, CTAs, NDAs, MAAs)
• Ensure compliance with reporting requirements and regulatory timelines
• Contribute to internal SOPs and work instructions

Conhecimentos

Regulatory submissions

Cross-functional collaboration

Regulatory guidelines US/international

Regulatory intelligence

Formação académica

Bachelor's degree + 10+ years in drug development

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

Descrição da oferta de emprego

Kailera Therapeutics, Inc. seeks an Associate Director of Global Regulatory Affairs to lead day-to-day regulatory activities for early/late phase investigational products.

You will direct IND/CTA submissions, guide regulatory filings, and provide regulatory intelligence across global programs, collaborating with CMC, Regulatory Operations, and cross-functional teams. The role emphasizes strategic regulatory leadership, risk management, and ensuring compliance with agency expectations while