Regulatory Affairs Specialist
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Winid is a talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.
Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people diversity and inclusion innovation and cutting-edge technology.
About the client:
We are working with a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS) currently seeking a Tech-Transfer Project Manager. The position is based in Barcelona and offers a hybrid work model.
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 addition the position provides administrative and technical support for regulatory activities before and after product authorization supporting the maintenance of marketing authorizations and the management of related variations.
Your major accountabilities:
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 crossfunctional teams (Supply Chain Commercial Quality PV International Trade).
Implement and maintain regulatory dossiers in eCTD 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 followup of regulatory correspondence.
Support submissions variations renewals notifications and postapproval activities including timeline tracking responses to authority questions and compliance with postapproval commitments.
Support audits inspections and customer requests (due diligences deficiencies CPPs statements samples) and review and approve artwork to ensure regulatory compliance.
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)
Bachelors in pharmacy or chemistry
