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Product Regulatory Lead
2 semanas atrás
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue.
About the RoleThe Regulatory Affairs Associate will be responsible for a range of regulatory activities, including compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
Key Responsibilities:
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Assists in the maintenance of compliance for all products with local regulations and quality system requirements.
Requirements
- Knowledge of consumer healthcare environment and product development.
- Understanding of processes and departments within a healthcare company.
- Effective time and organization management.
- Proficiency in English.