Associate Director, Global Regulatory Affairs

The role

The Associate Director, Global Regulatory Affairs will manage day-to-day regulatory activities for early and late phase investigational products. This role involves leading the writing and submission of IND/CTA/amendments and future marketing applications while providing regulatory guidance to cross-functional teams.

What you will do

• Serve as the regulatory representative on core teams
• Develop and plan regulatory submission strategies
• Coordinate the preparation of submissions to regulatory agencies
• Conduct regulatory intelligence activities
• Oversee the compilation, review, and submission of regulatory applications
• Monitor the regulatory environment and communicate developments to stakeholders
• Stay updated on global regulatory guidance and regulations
• Respond to regulatory questions from various regulatory authorities
• Provide strategic regulatory guidance for global development and registration programs
• Contribute to the implementation of processes and procedures

Required qualifications

• Bachelors degree with 10+ years of relevant drug development experience
• Knowledge of regulatory requirements in the design and conduct of clinical trials
• Working knowledge of regulatory guidelines and regulations (US and international)
• Deep knowledge of the integrated drug development process
• Ability to find solutions and alternatives through teamwork
• Ability to assess and manage risk in a highly regulated environment
• Strong written, spoken, and presentation communication
• Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities

Nice to have

• Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.