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Kailera TherapeuticsPosted 10/19/2026full-timeWaltham • Massachusetts • United StatesLead💰 $272,000 - $340,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in CMC Regulatory strategy and execution, with a strong focus on successful submissions to FDA and EMA. Proven ability to lead high-performing teams and establish strategic relationships with health authorities and CDMO partners.
Highest-signal resume keywords
CMC Regulatory Strategy DevelopmentFDA Submission ExperienceTeam Leadership and DevelopmentCross-Functional CollaborationBiopharmaceutical Industry Expertise
About the role
Key responsibilities & impact- Lead all aspects of CMC Regulatory
- Provide strategic and operational leadership to the CMC Regulatory team and integrated CMC team
- Develop and own the global CMC regulatory strategy for the portfolio
- Provide input to corporate and program strategy, including Phase 3 readiness, marketing application planning, and launch
- Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities
- Lead CMC-focused meetings and responses to information requests
- Ensure execution of CMC regulatory strategy
- Set standards and expectations for submission quality and cross-functional delivery
- Build, lead, and develop a high-performing CMC Regulatory team, including organizational design, hiring, succession planning, and coaching managers
- Oversee CMC-related submission planning and execution
- Ensure high-quality and accurate submission documents are completed within target timelines
- Interpret and discuss data with cross-functional teams and health authorities
- Anticipate evolving global regulatory expectations and industry trends, advise executive leadership, and adjust strategy
- Lead risk assessments on CMC regulatory topics and develop contingency and mitigation plans
- Establish strategic relationships with CDMO partners, health authorities, and internal executives
- Ensure CMC dossiers meet ICH and local country requirements
- Determine resourcing, budget, and use of external consultants and vendors
- Influence resource allocation across Process Development, Manufacturing, Analytical, and Quality
- Partner with Quality and Technical Operations on commercial manufacturing readiness, process validation, comparability, and pre-approval inspection strategy
- Define post-approval change and lifecycle management strategy
Requirements
What you’ll need- 15+ years of biopharmaceutical industry experience
- 10+ years of relevant Regulatory CMC experience
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Ability to motivate and lead others, both with direct line and within integrated team
- Excellent interpersonal, verbal and written communication skills
- Ability to effectively lead and influence others
- Comfortable in a fast-paced small company environment with minimal direction
- Able to adjust workload based upon changing priorities
- BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required
- Advanced degree preferred
- E-Verify employment eligibility confirmation for new hires
Benefits
Comp & perks- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus opportunities
- Equity grants
- Competitive compensation
- Innovative science
- Patient-focused company culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory CMC ExperienceSubmission Planning and ExecutionData Analysis and InterpretationRisk Assessment and MitigationPost-Approval Change Management
Soft Skills
Interpersonal CommunicationLeadership and MotivationAdaptability to Changing Priorities
Certifications & Qualifications
E-Verify Employment Eligibility
Industry Keywords
Biopharmaceutical IndustryICH RequirementsHealth AuthoritiesCDMO PartnershipsCommercial Manufacturing Readiness