Requirements: English
Company: G&L Scientific
Region: Catalonia
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.
Background:
- Bachelors or masters 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 salaries
- Benefits 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.