Excelya
Senior Regulatory CMC Project lead
Remote role where the employee must remain based in a particular country.
France only
Employer listed it 8 days ago · Found 2h ago
First listed 8 days ago and still open.
Salary
Not stated
Location
France only
Timezone
CET ±2
Contract
Full-time
Experience
Lead
Category
Operations
This employer didn't state pay. Jobs like this usually pay around $160k–$235k a year, a typical range taken from 138 lead-level operations roles on Nomaders that do state pay. It's a guide, not an offer.
Remote flexibility
Work from home
This is a remote role, but the employee must be based in France. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Saclay, France, Saclay, Île-de-France, France, Saclay, Île-de-France, France, Remote"
What Nomaders makes of it
- Residency required in France
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
About the Job
At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.
This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.
The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.
Main Responsibilities:
Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation)
Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset.
Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients.
Effective project management skills to ensure high quality and timely delivery of regulatory documents.
Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB).
Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed.
Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements
Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
Generate gap analysis and risk management support for each submission in the core markets as needed
Compile regulatory documents in support of each submission in the core markets on time and in line with 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 (EMA, FDA, ICH) and 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
Why Join Us?
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 (EMA, FDA, ICH) and lifecycle management principles.
- ·Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams.
- ·Excellent communication, analytical, and organizational skills
Benefits
- ·At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- ·Here’s what makes us unique—
- ·Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Excelya, mentioning your remote working experience and working hours (CET ±2).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 2h ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
Similar roles
Other open operations roles with comparable remote rules.
Free to apply, no account needed.
Typically $160k to $235k per year · You'll be taken to the employer's careers page.