Senior Regulatory CMC Project Lead

This is a fully remote position, open to applicants in France.

📋 Description

• Oversee the global CMC Regulatory strategy for a late-phase small molecule asset, currently preparing for MAA.

• Create, develop, manage, and implement the global CMC Regulatory strategy to optimize regulatory outcomes.

• Ensure that CMC Regulatory strategies facilitate potential expedited product development paths and enhance the speed of product delivery to patients.

• Oversee projects to guarantee the timely and high-quality delivery of regulatory documents.

• Guide the CMC strategy for interactions with regulatory agencies, including the preparation of the briefing book.

• Represent CMC Regulatory in cross-functional technical, regulatory, and governance meetings related to the asset as required.

• Provide CMC Regulatory assistance to the Regulatory CMC technical writing team regarding specific country requirements.

• Collaborate with local affiliates to formulate efficient regulatory strategies for delivering the CMC Dossier in alignment with country requirements and agreed timelines.

• Conduct gap analyses and offer risk management support for submissions in key markets.

• Prepare regulatory documents for timely submissions in key markets, adhering to country-specific requirements.

⛳️ Requirements

• Bachelor's degree in pharmacy, chemistry, pharmaceutical sciences, or a related discipline.

• Significant experience in CMC regulatory affairs focusing on small molecule lifecycle management, ideally within the pharmaceutical industry or consultancy.

• Comprehensive understanding of global regulatory frameworks, including EMA, FDA, and ICH.

• Familiarity with lifecycle management principles.

• Demonstrated capability to lead CMC regulatory projects and work effectively with multidisciplinary teams.

• Exceptional communication, analytical, and organizational abilities.

• Proficiency in English.

• French language proficiency is advantageous.

🏝️ Benefits

• Opportunity to work with Excelya, a mid-size CRO and health company.

• Exposure to diverse projects through a comprehensive service model that includes full-service, functional service provision, and consulting.

• Collaborate with leading experts in the field.

• Work environment that values natural talents, encourages pushing boundaries, and fosters professional growth.

• Chance to contribute to advancements in scientific, operational, and human knowledge, enhancing the patient's journey.