Misión
Consultoría especializada en servicios de Desarrollo y Regulatory Affairs para medicamentos veterinarios desinados a animales de producción y animales de compañía.
Productos y servicios
Experto en Asuntos Regulatorios. Elaboración de Solicitudes de Autorizaciones de Comercialización, redacción de datos químicos, preclínicos y clínicos (Procedimientos Nacionales, Reconocimiento Mutuo, Procedimientos centralizados y procedimientos descentralizados), proyectos post-autorización (extensiones de línea, variaciones, renovaciones).Asesoramiento científico y normativo para el diseño y desarrollo de estudios de calidad, estudios preclínicos y ensayos clínicos, incluida la elaboración de los protocolos, gestión de proyectos, seguimiento, desarrollo, monitorización y redacción de los informes.Servicios de farmacovigilancia.
Área de interés
Servicios de consultoría y contratación para el desarrollo y registro de medicamentos veterinarios desde tarea simple hasta proyectos muy complejos a nivel local o en la UE.
Ofertas de empleo en la Empresa
Regulatory Affairs Manager - Animal Health
Entidad: G&L ScientificDescripción: Are you an experienced Regulatory Affairs professional with a passion for animal health? Join our team as a Regulatory Affairs Manager and play a vital role within the G&L Scientific team.
This role focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.Plazo de solicitud: 15/05/2025Nombre: Nati VivesE-mail: nvives_arroba_gandlscientific.comTeléfono: 615966997 Responsibilities will include:
- Developing and executing regulatory strategies to support the registration of products in line with applicable regulatory requirements in the EU.
- Auditing dossiers and producing GAP analysis reports
- Preparing regulatory documentation for new MAAs in collaboration with stakeholders from R&D, Manufacturing, Quality Control and Quality Assurance.
- Preparing, developing and analyzing CMC, safety and efficacy documentation.
- Scientific Advice applications in EMA and/or local Authorities.
- VNeeS preparation and submissionManaging the authorization for animal health products according to national and EU regulations (MRP, DCP and centralized procedures).
- UPD, CESP, IRIS, SPOR and other portal management.
- Stay informed about current and pending regulations in veterinary medicinal products, with a strong focus on the EU.
- Plan and manage regulatory procedures on behalf of client companies.
- Ensure ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
Background:
- Bachelors or master’s degree in health science.
- Ideally, 5+ years in regulatory affairs, with at least 3 years specifically in Animal Health Pharmaceutical Industry.
- Working knowledge of EU markets, and other global regions would be advantageous.
- Familiarity with European animal health e-submission portals.
- Practical experience working with different National Competent Authorities (NCAs).
- Experience in clinical trials (CT Application, VIP applications and protocols development) would be a benefit.
- Experience in biological products is an advantage.
Skills & Competencies:
- Strong organizational and communication skills with the ability to manage multiple projects.
- Proactive and team-oriented mindset with a commitment to continuous learning.
- Excellent working knowledge of MS Office.
- Fluent written and spoken English and Spanish.
- High degree of attention to detail and troubleshooting skills.
- Flexible and adaptable, with innovative problem-solving abilities.
- Expert in interpreting regulatory requirements and determining compliance strategies.
Why working at G&L Scientific?
- Permanent contract.
- Competitive salariesBenefits package (medical insurance, disability insurance, pension plan and flexible remuneration)
- Flexible working schedule.
- Hybrid Model (2 days at Barcelona office)
- Wide variety of projects, new challenges and experiences.
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