Senior Regulatory CMC Project Lead

🔥 4 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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.

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

Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• Lead the global CMC Regulatory strategy for one small molecule asset in late phase, with MAA under preparation • Define, develop, own, and execute the global CMC Regulatory strategy while maximizing regulatory outcomes • Ensure CMC Regulatory strategies enable potential accelerated product development pathways and speed product delivery to patients • Manage projects to ensure high-quality and timely delivery of regulatory documents • Lead the CMC strategy for agency interactions, including preparation of the BB • Represent CMC Regulatory in asset cross-functional technical, regulatory, and governance meetings as needed • Provide CMC Regulatory support to the Regulatory CMC technical writing team regarding country requirements • Liaise with local affiliates to develop efficient regulatory strategies for delivering the CMC Dossier according to country requirements and agreed timelines • Generate gap analyses and provide risk management support for submissions in core markets • Compile regulatory documents for submissions in core markets on time and according to country requirements

🎯 Requirements

• Degree in pharmacy, chemistry, pharmaceutical sciences, or related field • Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, preferably within pharmaceutical industry or consultancy • Strong knowledge of global regulatory frameworks, including EMA, FDA, and ICH • Knowledge of lifecycle management principles • Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams • Excellent communication, analytical, and organizational skills • Fluency in English • French language skills are a plus

🏖️ Benefits

• Opportunity to work at Excelya, a health company and mid-size CRO • Diverse projects through a one-stop provider service model offering full-service, functional service provider, and consulting • Work alongside preeminent experts • Environment that values natural talents, pushes boundaries, and nurtures professional potential • Opportunity to contribute to improving scientific, operational, and human knowledge and enhancing the patient’s journey