In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Spain.
You will be part of a team of Regulatory Affairs professionals dedicated to Southern Europe, with the mission to develop the Regulatory Affairs presence and take responsibility for new regulatory activities related to Spain for several clients.
Responsibilities include:
- Providing guidance and support for managing submissions and other requests from clients regarding Spain.
- Contributing to regulatory activities such as pre-licensing, new registration (sites and medicinal products), and post-approval applications.
- Assisting with the preparation of Marketing Authorization Applications (MAAs).
- Preparing and submitting documentation for post-approval applications, including Type IA, Type IB, Type II, Renewals, MAH Transfers / COAs.
- Preparing and submitting Technical / Site Transfer Applications.
- Assisting with license applications as required.
- Managing artwork generation, labeling, and creation/update of product information, including review of packaging texts and format review of SmPC, PILs, and labels for QRD compliance.
- Responding to internal requests for technical and regulatory information.
- Ensuring compliance with regulatory processes in preparation for audits.
- Monitoring and maintaining up-to-date knowledge of national and European guidelines and legislation.
- Using software tools such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat to produce documents, maintain data, and locate information.
- Performing general regulatory administration duties and ensuring compliance.
- Documenting and tracking regulatory submissions and approvals.
- Contributing to data entry in PLG tools for KPI and metric measurement.
Education:
- At least a Bachelor's Degree in Life Sciences, preferably in Pharmacy.
Experience:
- Minimum of 5 years in Regulatory Affairs within a pharmaceutical company or service provider.
- Experience with ES Lifecycle Maintenance (LCM) and Category 1 Drugs.
- Experience with new drug registrations is preferred.
Skills:
- Excellent organizational and interpersonal skills.
- Strong coordination abilities.
- Proven ability to meet tight deadlines without compromising quality or budget.
- Ability to work independently and within a team.
- Effective prioritization and multi-tasking skills.
- Process-oriented with keen attention to detail.