Note Candidates who can join immediately can apply
Job Description Regulatory Affairs Intern
Overview
We are seeking a highly motivated and experienced person to join our team
Responsibilities:
- Participate in the development of regulatory submission and approval strategy in multiple countries.
- Maintain awareness and understanding of new and existing regulatory requirements.
- Support identification of applicable regulatory requirements their impact and how to interpret them.
- Support on generating the required documentation for various submissions
- Assemble regulatory submission package and support submission process.
- Support audits and inspections by regulatory authorities or notified bodies.
- Assist in the creation revision and maintenance of QMS documentation including SOPs work instructions and forms.
- Support the coordination and documentation of employee training related to the QMS and regulatory requirements.
- Assist in the administration and tracking of Corrective and Preventive Actions (CAPA).
- Participate in continuous improvement initiatives to enhance the effectiveness of the QMS.
regulatory affairs,documentation,forms,maintenance