Senior Manager, 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:

Reporting to the Senior Director of Regulatory Operations, the Senior Manager, Regulatory Operations plays a pivotal role in supporting global clinical trial application (CTA) submissions, with a focus on Phase 3-enabling studies. This role ensures timely tracking, seamless coordination of handoffs and approvals, and quality control of submission components in compliance with global regulatory requirements and internal standards.

In close collaboration with the Regulatory Strategy Lead and cross-functional teams, the Senior Manager will drive operational excellence, maintain inspection-ready documentation, and support the advancement of clinical programs into late-stage development.

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

Responsibilities:

• Coordinate the preparation, quality review, and handoff of CTA components to CROs, ensuring submission readiness and compliance with health authority and internal standards
• Collaborate with the Regulatory Strategy Lead and study team members to ensure consistency and alignment with internal standards across submission activities
• Attend study team meetings, tracking submission status, and follow up with CRO contact(s) as necessary
• Maintain accurate, inspection-ready regulatory records to support audits and health authority inspections
• Track CRO delivery of final archival copies and ensure complete, properly indexed records in regulatory systems (e.g., Veeva RIM), and crosslinking as appropriate to the eTMF
• Create and maintain global CTA submission chronologies to support reporting and metrics
• Archive final submissions and correspondence; follow up on missing documentation as needed
• Manage user access and permissions for the Clinical Trials Information System (CTIS), ensuring compliance with regulatory and organizational requirements
• Create user guides and instructions for CTIS system use, and provide training as needed
• Contribute to the enhancement of regulatory operations processes, templates, and tools
• Lead or participate in special projects that support the strategic goals of the Regulatory Operations team

Required Qualifications:

• 8+ years of relevant experience in a Regulatory Operations or related role
• Knowledge of Agency regulations, industry standards, and CTD/eCTD requirements pertaining to regulatory operations
• Understanding of the drug development process
• Regulatory submissions experience with CTAs and eCTD format for INDs and/or NDAs
• In-depth experience in document management and regulatory publishing
• Excellent verbal, written, strong organizational and time management skills, and ability to think strategically
• Must have a strong attention to detail and skill in compiling/reviewing submission documents to ensure compliance with regulatory publishing standards
• Proficient with publishing tools/eCTD software, EDMS/RIM, MS Word, Word templates, Adobe Acrobat and standard Office tools
• Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines
• Experience with Veeva Vault RIM required
• EU CTR and CTIS portal management experience required

Education:

• BA/BS degree in science or health related field

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.

 #LI-Hybrid