• 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.

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.