Requirements: English
Company: G&L Scientific
Region: Barcelona , Catalonia
Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team. This role focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.
Responsibilities may include:
- Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
- Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
- Working on safety, efficacy and CMC variations: variation typification and documentation preparation.
- Supporting R&D, manufacturing, quality control and quality assurance departments for potential queries.
- Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
- 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.
- Managing the authorisation according to national and EU regulations (MRP, DCP and centralized procedures).
- Ensuring all project work aligns with current regulatory guidance and meets internal standards.
Background:
Bachelors or masters degree in health science.
Experience:
- 7+ years in regulatory affairs, with at least 3 years of experience in pharmaceutical company.
- Familiarity with European e-submission portals.
- Practical experience working with different National Competent Authorities (NCAs).
- Experience of small and large molecules, ideally across multiple therapy areas/dosage forms.
- Working experience in writing and reviewing module 3, module 4 and module 5.
- Experience in biological products would be a bonus.
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. Analytical skills and ability to summarize.
- 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.