Regulatory Affairs

21 hours ago


Bengaluru, Karnataka, India Dozee Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year
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.


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