Regulatory Affairs Manager

buscojobs España; Ciudad Real; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

G&L Scientific seeks a Regulatory Affairs Manager to lead compliance efforts within the Animal Health sector. This role involves developing regulatory strategies, managing documentation, and ensuring compliance with EU regulations. The ideal candidate will possess a health science degree and significant experience in the field, demonstrating strong communication and organizational skills.

Servicios

Permanent contract

Medical insurance

Disability insurance

Pension plan

Flexible remuneration

Variety of projects and experiences

Formación

• 5+ years in regulatory affairs with focus on Animal Health.
• Working knowledge of EU markets and e-submission portals.
• Experience in clinical trials is beneficial.

Responsabilidades

• Develop regulatory strategies for product registration.
• Prepare and manage regulatory documentation.
• Ensure compliance throughout product lifecycle.

Conocimientos

Organizational skills

Communication skills

Attention to detail

Problem-solving

Team-oriented mindset

Fluency in English

Fluency in Spanish

Educación

Bachelor's or Master's degree in health science

Herramientas

MS Office

Descripción del empleo

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.

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 submission
• Managing 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.
• 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.
• 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.
• Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
• Hybrid Model (2 days at Barcelona office)
• Wide variety of projects, new challenges and experiences.

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