Vice President Regulatory CMC

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:

Vice President of CMC Regulatory will lead all aspects of CMC Regulatory.  Reporting into the Sr. VP of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team.   With their lead candidate planning to initiate Phase 3, the candidate must plan for have extensive drug development expertise.  The company offers innovative science, competitive compensation and a patient-focused company culture.

Responsibilities:

• Lead the development and implementation of all CMC regulatory strategies to support global development programs, and market applications.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Ensure the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
• Oversee all CMC-related submission planning and execution, ensuring that high‑quality and accurate submission documents are completed within target timelines.
• Accurately interpret and discuss data within cross-functional teams and with health authorities.
• Actively seek out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
• Lead the preparation of risk assessments on CMC regulatory topics. Predict potential regulatory questions and develop robust contingency and mitigation plans with the integrated CMC team.
• Build and manage relationships through active partnering with key internal and external stakeholders.
• Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.

Qualifications:

• BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required; advanced degree preferred.
• 20+ years of biopharmaceutical industry experience; with 15+ years of relevant biologics experience in Regulatory CMC.
• 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 as well as the ability to effectively lead and influence others
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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.