Regulatory Affairs Manager - Animal Health
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.
The Role
Key Responsibilities:
- 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 R&D, Manufacturing, Quality Control, and Quality Assurance stakeholders.
- 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.
- Staying informed about current and pending regulations in veterinary medicinal products, with a strong focus on the EU.
- Planning and managing regulatory procedures on behalf of client companies.
- Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
Requirements
Experience:
- Bachelor's 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.
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.
- Expertise in interpreting regulatory requirements and determining compliance strategies.
Why Join Us?
- Permanent contract.
- Competitive salaries.
- Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
Flexible working schedule. - Hybrid Model (2 days at our Barcelona office)
- Wide variety of projects, new challenges and experiences.
How to Apply
If you would like to hear more, please send your details to: talent@gandlscientific.com today!
G&L is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
