Senior Director, Global Regulatory Affairs

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You'll Do:

The Senior Director of Global Regulatory Science will serve as a key team member for assets in development providing regulatory expertise and insight into the development plan resulting in competitive, complete, and on time submissions in Rest of World Markets including Japan.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Develop and implement a global regulatory strategy which supports development, registration, and lifecycle maintenance in ROW markets for early and late-stage development programs.
• Execute regulatory strategy by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities.
• Develop and implement innovative approaches and solutions, and drive acceleration strategies.
• Interact directly with and lead regulatory agency meetings for designated markets.
• Serve as department point person for regulatory competitive intelligence.
• Review clinical trial-related documentation for compliance with regulatory guidance.
• Lead, author and evaluate documents submitted to regulatory health authorities.
• Contribute to the implementation of processes and procedures.
• Provide organizational responsibilities such as labeling strategy, independent regulatory strategy and problem-solving assignments.

Required Qualifications:

• 10+ years of relevant drug development experience.
• Industry related experience in regulatory affairs.
• Experience in international regulatory submissions and regulatory interactions.
• Previous regulatory or leadership assignments across multiple countries.
• Demonstrated deep knowledge of the integrated drug development process.
• Demonstrated ability to find solutions and alternatives through teamwork.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Strong written, spoken and presentation communication.
• Demonstrated negotiation and influence skills.
• Willingness to travel between 10-15%.

Preferred Qualifications:

• Experience in the GLP-1 space preferred.

Education:

• Advanced degree (such as PhD, PharmD, MS, MBA) preferred.

Benefits of Working at Kailera:

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

• Comprehensive health benefits and tax-advantaged savings accounts.
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown.
• Monthly wellness stipend.
• Generous 401(k) match.
• Disability and life insurance.

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range: $210,000 - $270,000 USD

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

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