Regulatory Affairs Associate
Regulatory Affairs Associate
Posted on :
25-10-2024
Employer Active
1 Vacancy
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Job Description
Our client is a leading pharmaceutical company in Nigeria.
JOB SUMMARY
The Regulatory Affairs Associate will support the regulatory affairs department in managing submissions compliance documentation and communication with regulatory agencies. This role involves ensuring that products are developed manufactured and marketed in accordance with applicable regulations and guidelines.
Key Responsibilities
- Develop and maintain good working relationships with the Health Authorities providing feedback from Health Authorities regarding submissions made or any relevant changes (processes guidelines etc.)
- Prepare applications and ensure submissions for postapproval changes (variations) are made and follow up with the Health Authority for timely approval.
- Maintain prompt submission of post approval commitments and other changes and provide timely responses to HA as required
- Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management
- Maintain adherence to Global and local/regional processes with respect to lifecycle maintenance activities.
- Ensure issues of noncompliance are handled with urgency and appropriate channels are engaged promptly where necessary.
- Ensure compliance to local and global KPls.
Requirements
- Minimum of B. Pharm
- 12 years of experience in a similar role
- Good communication and negotiation skills.
- Strong Knowledge of CTD dossier format
- Detailoriented organized and interpersonal skills
Employment Type
Full Time
Key Skills
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