Regulatory Affairs Manager
Are you an experienced Regulatory Affairs professional?
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 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 authorization according to national and EU regulations (MRP, DCP and centralized procedures).
- Ensuring all project work aligns with current regulatory guidance and meets internal standards.
Requirements
Experience:
- Bachelor's or Master’s degree in health science.
- Ideally, 7+ years in regulatory affairs, with at least 3 years specifically in the Pharmaceutical Industry.
- 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.
- 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.
