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.
* Wide variety of projects, new challenges and experiences.