Senior Director, Regulatory Operations

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 Regulatory Operations will be responsible for formulating and implementing the Regulatory Affairs Operations vision and strategy to establish capabilities, systems and process to support global submissions. The role will involve envisioning and implementing digital innovation for compliance and efficiency while working with supporting functions.

Responsibilities:

• Ensures that Kailera has the process and systems in place to meet technical requirements for CTD submissions.
• Establishes processes for efficient, timely, and compliant submissions
• Accountable business owner for a regulatory document management system to support global submissions, including continuity plans, audit readiness, and training of staff.
• Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the department.
• Supervisor of regulatory operations associates and contracted staff
• Ensure conformance with all regulatory submission SOPs, local and international regulations, and industry best-practice.

Qualifications

• Minimum BS degree; advanced degree (MS, MBA, PhD, or MD) preferred with 15+ years of industry experience in and or around drug development with responsibilities for major aspects of strategic planning, implementation, and project management.
• Management experience in pharmaceutical or related field with a proven record of leading and driving business process transformation and organizational culture change.
• Comprehensive understanding of the pharmaceutical industry, R&D, and regulatory affairs
• Experience managing complex global partnerships and innovation ecosystems.
• Project-management expertise demonstrated ability to lead complex outsourcing projects.
• Deep understanding of regulatory information management

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), 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.

E-Verify:

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

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