
Regulatory Compliance Officer
2 weeks ago
Regulatory Affairs Specialist
Job Description:
Assist the Regulatory Affairs Manager in regulatory activities for clinical trials and marketing authorisation.
This includes submitting applications and variations across all pipelines, supporting regulatory assessments of submission requirements based on relevant regulations, assisting with administrative work necessary to support regulatory activities, reviewing and providing input for regulatory documents, and more.
Responsibilities:
- Assist with submissions of applications and variations for clinical trials and marketing authorisation across all pipelines
- Support regulatory assessment of submission requirements based on relevant regulations
- Assist with administrative work necessary to support regulatory activities
- Review and provide input for regulatory documents
- Assist doctors in preparation of study protocols and other regulatory matters
- Lead regulatory preparations for customer audits, certification bodies, and regulatory inspections
- Assist in evaluating new products and services to ensure regulatory compliance
- Maintain records and help respond to regulatory inquiries
- Ensure product labels meet regulatory requirements and coordinate with marketing/design teams
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