About This Role
This role is for a Regulatory Affairs Specialist joining a team of specialists who report directly to the Head of Global Regulatory Affairs. The selected candidate will collaborate with the team on regulatory documentation for human medicines.
Responsibilities
- Draft, update, and manage regulatory documentation for the development and registration of human medicines in various geographical areas, collaborating with other company functions and external partners
- Support the drafting and submission of documentation required for variations and post-authorization procedures, such as renewals and/or post-approval commitments
- Support and coordinate the registration of medicines and related post-authorization phases in collaboration with business partners, acting as the primary contact for regulatory activities and documentation requests in collaboration with the QC, QA, R&D, and production departments
- Support the preparation of regulatory documentation for the clinical phases of products under development (e.g., Investigational New Drug Application in the US or Clinical Trial Application in the EU)
- Draft, review, and maintain quality regulatory documents (module 3 and 2.3) for new registrations, variations, renewals, and clinical trial applications
- Ensure the alignment of quality information in various geographical areas with production and control practices
- Maintain and update printed materials (SmPC, PIL, and labelling texts) in accordance with EU regulatory requirements, coordinating the appropriate implementation of changes in collaboration with internal functions (medical, pharmacovigilance, quality, supply chain)
- Review and approve artwork and packaging materials, ensuring compliance with printed materials and current regulations
Requirements
- Degree in scientific disciplines, preferably Pharmaceutical Chemistry and Technology (CTF) or Pharmacy
- At least 3 years of experience in similar roles, ideally in Italian pharmaceutical companies with international exposure, with a focus on human medicines
- Fluent knowledge of English, both written and spoken (any certification will be considered a plus)
- Solid proficiency in the Microsoft Office suite
Nice to have:
- Participation in courses or specialization schools in regulatory affairs
- Knowledge of software and CTD
- Excellent teamwork skills
- Flexibility, precision, and excellent organizational skills
Application Process
- Email your CV, résumé or portfolio, and a cover letter explaining your motivation for applying
- Include the job title in your email subject line
About the Company
COSMO IMD is a company operating in Regulatory Affairs.
