Regulatory Affairs Manager

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.

J-18808-Ljbffr

J-18808-Ljbffr