Director, Regulatory Affairs (Device/Combination Products)

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 Director of Regulatory Affairs, Device and Combination Product will be responsible for the development and execution of global device and combination product strategies across multiple assets. This individual will ensure that the regulatory strategies are effectively implemented and aligned with changing regulatory and business needs. Additionally, this individual will work seamlessly with cross-functional teams and will exhibit strong technical knowledge to deliver against aggressive development timelines.

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

Responsibilities :

• Lead device and combination product regulatory activities for multiple assets
• Provide device and combination product technical and global regulatory advice / guidance to CMC teams by defining and developing regulatory strategies
• Develop and lead device / combination product related dossier content for global regulatory submissions (i.e. IND, CTA, MAA, NBO, Technical Files, etc.) for both clinical and commercial applications
• Analyze and manage complex combination product and device related risk
• Collaborate cross-functionally with CMC teams, quality, regulatory strategist and other functions to ensure effective strategies are developed and projects are on track
• Build and maintain relationships through actively partnering with stakeholders (technical operations, regulatory affairs, product teams, etc.)
• Represent Device / Combination Product regulatory in audits and inspections
• Manage and lead Health Authority interactions (FDA, EMA, NBO, etc.)
• Must understand and be able to communicate scientific principles and regulatory principles to regulatory requirements relevant to global drug-device combination product development

Required Qualifications :

Education :

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.

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

175,000-$230,000 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 (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

Salary : $175,000 - $230,000