About the client: We are working with a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, including both psychiatric and neurological disorders.
Job description
The main focus of the role is to prepare, manage, and submit regulatory documentation to Health Authorities and customers in both European and non-European markets, ensuring full compliance with regulatory requirements, internal procedures, and quality standards throughout the product lifecycle. The position also supports administrative and technical activities for regulatory actions before and after product authorization, maintaining marketing authorizations and managing related variations.
Responsibilities
* Prepare, manage, and submit Quality and Labelling variation packages, providing regulatory expertise to support product registration and lifecycle management.
* Review and evaluate regulatory dossiers, including support to technological transfers and updates to pharmaceutical documentation.
* Compile and manage documentation for Marketing Authorization Transfers (MAT) across multiple markets, in close collaboration with cross‑functional teams (Supply Chain, Commercial, Quality, PV, International Trade).
* Implement and maintain regulatory dossiers in e‑CTD format, prepare baselines, and ensure accurate updates in the RIM system and internal document repositories.
* Manage and maintain regulatory records, submissions, and product files to ensure compliance and audit readiness.
* Act as regulatory liaison with Health Authorities, customers, and external consultants, including preparation and follow‑up of regulatory correspondence.
* Support submissions, variations, renewals, notifications, and post‑approval activities, including timeline tracking, responses to authority questions, and compliance with post‑approval commitments.
* Support audits, inspections, and customer requests (due diligences, deficiencies, CPPs, statements, samples), and review and approve artwork to ensure regulatory compliance.
Qualifications
* Minimum 5 years of experience as a RA Specialist.
* Experience in the 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.
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