REGULATORY AFFAIRS MANAGER
Solo Talento
| (13) ofertas activas
Barcelona, Madrid 27 Oct.
Somos una compañía de recursos humanos con más de 20 años de experiencia que ofrece Servicios de Consultoría de RRHH y de Selección de mandos intermedios, puestos técnicos y perfiles profesionales a nivel nacional e internacional.
Realizamos operaciones en numerosos sectores estratégicos de manera rápida y ágil gracias a la experiencia de nuestros consultores especializados.
Empresa que ofrece el puesto: A leading European company in the animal health sectorRealizamos operaciones en numerosos sectores estratégicos de manera rápida y ágil gracias a la experiencia de nuestros consultores especializados.
Barcelona, Madrid 27 Oct.
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Descripción A leading European company in the animal health sector, dedicated to the development, registration, and commercialization of veterinary pharmaceutical products for both companion animals and production animals is looking to hire a Regulatory Affairs professional that can be based in Madrid or Barcelona.
Main Purpose of the Role
To manage the regulatory lifecycle of veterinary pharmaceutical products across Europe, ensuring compliance with marketing authorisations and current Good Manufacturing Practice. The role involves preparing and maintaining regulatory dossiers and supporting product registrations across all species.
Key Responsibilities
Prepare and maintain the diferent sections of regulatory dossiers.
Collaborate with CDMOs and internal teams to ensure all required documentation is delivered to regulatory standards.
Draft new product dossiers and detailed and critical summaries in line with project timelines.
Respond to regulatory authority queries during and after registration processes.
Manage post-authorisation activities, including variations, compliance updates, and lifecycle documentation.
Coordinate artwork translations and approvals for distribution products.
Maintain and update the regulatory database.
Stay current with EU and international regulatory guidelines
Descripción A leading European company in the animal health sector, dedicated to the development, registration, and commercialization of veterinary pharmaceutical products for both companion animals and production animals is looking to hire a Regulatory Affairs professional that can be based in Madrid or Barcelona.
Main Purpose of the Role
To manage the regulatory lifecycle of veterinary pharmaceutical products across Europe, ensuring compliance with marketing authorisations and current Good Manufacturing Practice. The role involves preparing and maintaining regulatory dossiers and supporting product registrations across all species.
Key Responsibilities
Prepare and maintain the diferent sections of regulatory dossiers.
Collaborate with CDMOs and internal teams to ensure all required documentation is delivered to regulatory standards.
Draft new product dossiers and detailed and critical summaries in line with project timelines.
Respond to regulatory authority queries during and after registration processes.
Manage post-authorisation activities, including variations, compliance updates, and lifecycle documentation.
Coordinate artwork translations and approvals for distribution products.
Maintain and update the regulatory database.
Stay current with EU and international regulatory guidelines
Número de vacantes:
1
Modalidad de trabajo:
Presencial
Tipo de contrato:
Indefinido
Requisitos
Your Profile
At least 3years of experience in Regulatory Affairs within the veterinary pharmaceutical industry.
Strong knowledge of EU regulatory frameworks; experience with EMA is essential. Familiarity with FDA is a plus.
Experience with CMC modules and full product lifecycle management.
Degree in Pharmacy, Chemistry, Veterinary Sciences, or a related scientific field.
Excellent English (spoken and written); other European languages are a plus.
Strong attention to detail, autonomy, and ability to manage complex documentation.
Willingness to travel occasionally (~10%).
Location: Madrid, Barcelona or UK. Hybrid/ Remote possible depens on the location.
With a strong presence across multiple European countries, the company is known for its stable growth, positive work culture, and commitment to innovation and compliance
At least 3years of experience in Regulatory Affairs within the veterinary pharmaceutical industry.
Strong knowledge of EU regulatory frameworks; experience with EMA is essential. Familiarity with FDA is a plus.
Experience with CMC modules and full product lifecycle management.
Degree in Pharmacy, Chemistry, Veterinary Sciences, or a related scientific field.
Excellent English (spoken and written); other European languages are a plus.
Strong attention to detail, autonomy, and ability to manage complex documentation.
Willingness to travel occasionally (~10%).
Location: Madrid, Barcelona or UK. Hybrid/ Remote possible depens on the location.
With a strong presence across multiple European countries, the company is known for its stable growth, positive work culture, and commitment to innovation and compliance
Áreas terapéuticas
Veterinaria
Estudios mínimos
Licenciado en Ciencias de la Salud
Especialidad: Degree in Pharmacy, Chemistry, Veterinary Sciences
Especialidad: Degree in Pharmacy, Chemistry, Veterinary Sciences
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
El 20% del tiempo laboral