Associate Director, Global Regulatory Affairs

🔥 4 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $155k - $190k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Serve as the regulatory representative on core teams • Develop and plan regulatory submission strategies • Coordinate preparation of submissions to regulatory agencies • Conduct regulatory intelligence activities • Oversee compilation, review, and submission of regulatory applications and submissions, ensuring accuracy, completeness, and timeliness • Monitor the regulatory environment and communicate developments to clinical, regulatory, senior leadership, and other stakeholders • Stay updated on global regulatory guidance and regulations • Communicate key regulatory updates to senior leadership and project team management • Ensure compliance with reporting requirements, including annual and periodic reports • Respond to regulatory questions from authorities in collaboration with clinical development, safety, and other subject matter experts • Provide strategic regulatory guidance for global development and registration programs, including INDs, CTAs, NDAs, and MAAs • Assess and communicate regulatory requirements • Contribute to processes and procedures, including authoring internal work instructions and company SOPs

🎯 Requirements

• Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions • Established working knowledge of US and international regulatory guidelines and regulations • Demonstrated deep knowledge of the integrated drug development process • Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes • Demonstrated ability to assess and manage risk in a highly regulated environment • Strong written, spoken, and presentation communication • Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities • Travel expected (10-15%) • Bachelor's degree with 10+ years of relevant drug development experience OR advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience

🏖️ Benefits

• 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