Senior Regulatory CMC Project lead

Responsibilities

We are representing a confidential pharmaceutical organization seeking a Senior Regulatory CMC Project Lead to guide the global regulatory strategy for small molecule assets in late-phase development. In this role, you will:

• Lead the global CMC regulatory strategy for small molecule products preparing for Marketing Authorization Applications
• Define, develop, and execute regulatory strategies that maximize outcomes and enable accelerated development pathways
• Manage and deliver CMC dossiers with support from technical writing teams, ensuring high-quality and timely submissions
• Direct CMC strategy for all agency interactions, including preparation of briefing books
• Represent CMC regulatory interests in cross-functional technical, regulatory, and governance meetings
• Provide regulatory support to technical writing teams regarding country-specific requirements
• Collaborate with local affiliates to develop efficient regulatory strategies aligned with country requirements and timelines
• Generate gap analyses and risk management support for submissions across core markets
• Compile regulatory documents for submissions in compliance with country-specific requirements and deadlines

What We're Looking For

• Degree in pharmacy, chemistry, pharmaceutical sciences, or related field
• Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, within pharmaceutical industry or consultancy settings
• Strong knowledge of global regulatory frameworks including EMA, FDA, and ICH guidelines
• Deep understanding of lifecycle management principles for pharmaceutical products
• Proven ability to lead CMC regulatory projects and collaborate effectively with multidisciplinary teams
• Excellent communication, analytical, and organizational skills
• Fluency in English required; French language skills are advantageous
• Experience with late-phase development and MAA preparation highly preferred

How We Work With You

Our talent team at Get A Job.ai partners with you throughout the entire process. When you apply through our platform, a recruiter will conduct an initial screening to understand your background and ensure alignment with the role requirements. We will then submit your profile to our client for consideration. Please note that you should not contact the client organization directly—all communication will be coordinated through Get A Job.ai to ensure a smooth and professional process.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

Equal Opportunity: Get A Job.ai is committed to fostering an inclusive recruitment process. We welcome applications from candidates of all backgrounds and work to ensure fair consideration throughout our screening and submission process.