You will lead regulatory projects, prepare submissions, conduct data gap analyses, and provide strategic advice to ensure compliance with EU Regulation 1107 / 2009.
Key Responsibilities
- Manage regulatory projects for the registration of active substances.
- Prepare and review regulatory submissions ensuring compliance with EU requirements.
- Conduct data gap analyses, prepare dossiers, and perform risk assessments.
- Liaise with clients, authorities, and teams to address regulatory requests and issues.
- Develop regulatory strategies to facilitate product registration and market entry.
Requirements
5-10 years experience in regulatory affairs related to EU Regulation 1107 / 2009.Strong background in risk assessment for any section of the regulatory dossier.Proven experience in preparing and submitting regulatory dossiers for active substances.We are seeking an experienced professional to join our team as a Regulatory Affairs Expert. This role requires strong knowledge of EU Regulation 1107 / 2009 and experience in leading regulatory projects.