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
#J-18808-Ljbffr