Associate Director – Program Management, Regulatory Submissions

🔥 10 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $155k - $235k / year

⏰ Full Time

🟠 Senior

📋 Program Manager

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Kailera Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2024

🔥 Funding within the last year

💰 $600M Series B - Kailera Therapeutics on 2025-10

Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive clinical trial results in obesity in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com.

📋 Description

• Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements • Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing) • Oversee project team delivery of the marketing authorization applications • Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements • Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency • Own program reports / dashboards to executive and other governance teams • Establish best practices and SOPs as needed for marketing application related submission processes

🎯 Requirements

• 10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry • Strong understanding of drug development and how biotech functions integrate • Experience in managing cross-functional teams and complex projects in late-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred • Demonstrated project management and interpersonal skills • Excellent problem-solving and organizational skills, attention to detail, and analytical skills • Ability to manage multiple priorities in a fast-paced, dynamic environment • Comfortable navigating ambiguity and driving clarity • Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment • Proven record of collaboration and excellent communication • Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)

🏖️ Benefits

• comprehensive health coverage • flexible time off • paid holidays • year-end shutdown • monthly wellness stipend • generous 401(k) match • tuition reimbursement • commuter benefits • disability and life insurance • annual bonus opportunities • equity grants