Regulatory Affairs CMC Project Lead coordinating multiple pharmaceutical projects at Sanofi. Providing strategic regulatory guidance, mentoring team members, and ensuring compliance in drug development.
About the role
- Regulatory Affairs Specialist managing regulatory documentation for a European pharmaceutical company. Ensuring compliance with health authorities and supporting product lifecycle management in a hybrid model.
Responsibilities
- Prepare, manage, and submit regulatory documentation to Health Authorities and customers in both European and non-European markets
- Ensure full compliance with regulatory requirements, internal procedures, and quality standards throughout the product lifecycle
- Provide administrative and technical support for regulatory activities before and after product authorization
- Support the maintenance of marketing authorizations and the management of related variations
- Prepare, manage, and submit Quality and Labelling variation packages
- Compile and manage documentation for Marketing Authorization Transfers (MAT)
- Implement and maintain regulatory dossiers in e‑CTD format
- Manage and maintain regulatory records, submissions, and product files to ensure compliance and audit readiness
- Act as regulatory liaison with Health Authorities and external consultants
Requirements
- Minimum 5 years of experience as RA Specialist
- Experience in Pharmaceutical Industry
- Strong knowledge of MS Office (Excel, Power Point, Word)
- Knowledge of database management (Open Text)
- Knowledge of e-CTD software (Liquent)
- Strong problem-solving skills and willingness to learn.
- Good communication and multidisciplinary teamwork abilities with technical and non-technical users.
- Language: English and Spanish (fluent) and French (desirable)
- Bachelor’s in pharmacy or chemistry
Benefits
- Flexible working arrangements
- Professional development
- Support for regulatory activities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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