
Regulatory Affairs Associate
8 hours ago
Job Description
This role is responsible for assisting in regulatory activities for clinical trials and marketing authorisation. The individual will assist with submission of applications and variations across all pipelines, support regulatory assessment of submission requirements, and conduct administrative work necessary to support regulatory activities.
Responsibilities:- Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines.
- Support regulatory assessment of submission requirements based on relevant regulations.
- Conduct administrative work necessary to support regulatory activities.
- Review and provide input for regulatory documents.
- Assist the 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.
- Review marketing materials, regulatory changes, and related items.
The ideal candidate should possess a degree in Biological, Chemistry, or a related field and have an interest in Regulatory Affairs. A keen learner with strong attention to detail and organisational skills is required. Proficiency in English (written and spoken) is essential.
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