Announced
31/10/20245 days ago
Job Status
Full Time
Job Type
Employee
Expiration Date
29/11/2024 24 days left
Job Location
1st Otwe Street
Job Title
Regulatory Affairs AssociateJob Presentation
Our client, a leading pharmaceutical company is seeking a highly efficient and proactive individual to provide administrative support to the regulatory affairs unit as a Regulatory Affairs Associate.
ROLE PROFILE
The successful candidate will be responsible for supporting the Regulatory Affairs (RA) Team with lifecycle maintenance activities and assist in preparing submissions for post-approval changes, follow up with health authorities to ensure the timely conclusion of submitted applications and escalate issues when necessary. He or She will maintain all required regulatory databases, such as DRAGON, to ensure ongoing regulatory compliance and perform the following duties as well:
DUTIES AND RESPONSIBILITIES
Prepare applications and ensure that submissions for post-approval changes (variations) are made, following up with the Health Authority for timely approval.
Maintain prompt submission of post-approval commitments and other changes, and provide timely responses to the Health Authority as required.
Follow up with Chemistry, Manufacturing, and Controls (CMC) and Technical Operations for responses to deficiency letters received for submitted variations.
Maintain adherence to global and local/regional processes with respect to life-cycle maintenance activities.
Review the Health Authority website regularly to ensure that current information and updated guidelines are shared with the Regulatory Affairs (RA) team, and ensure relevant regulatory databases are up-to-date and accurate.
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.)
Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary.
Ensure compliance to local and global KPls.
Develop and maintain good working relationships with other functions/departments both locally and globally as well as with Health Authorities as required.
Support Regulatory Affairs (RA) projects and activities as assigned by Regulatory Affairs (RA) Managers and Regulatory Affairs (RA) Specialist.
Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.
Education: First Degree
ROLE PROFILE
The successful candidate will be responsible for supporting the Regulatory Affairs (RA) Team with lifecycle maintenance activities and assist in preparing submissions for post-approval changes, follow up with health authorities to ensure the timely conclusion of submitted applications and escalate issues when necessary. He or She will maintain all required regulatory databases, such as DRAGON, to ensure ongoing regulatory compliance and perform the following duties as well:
DUTIES AND RESPONSIBILITIES
Prepare applications and ensure that submissions for post-approval changes (variations) are made, following up with the Health Authority for timely approval.
Maintain prompt submission of post-approval commitments and other changes, and provide timely responses to the Health Authority as required.
Follow up with Chemistry, Manufacturing, and Controls (CMC) and Technical Operations for responses to deficiency letters received for submitted variations.
Maintain adherence to global and local/regional processes with respect to life-cycle maintenance activities.
Review the Health Authority website regularly to ensure that current information and updated guidelines are shared with the Regulatory Affairs (RA) team, and ensure relevant regulatory databases are up-to-date and accurate.
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.)
Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary.
Ensure compliance to local and global KPls.
Develop and maintain good working relationships with other functions/departments both locally and globally as well as with Health Authorities as required.
Support Regulatory Affairs (RA) projects and activities as assigned by Regulatory Affairs (RA) Managers and Regulatory Affairs (RA) Specialist.
Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.
Education: First Degree
Requirements
- EDUCATION/EXPERIENCE
- A minimum of a Bachelors Degree in Pharmacy or a related field.
- A minimum of one year work experience in the Regulatory Affairs field.
- Must have excellent knowledge of Common Technical Document (CTD) dossier format.REQUIREMENTS
- Must be Fluent in the English language.
- Should posses good communication and negotiation skills
- Must be detail oriented and well organized.
- Should be a team player and have a very good interpersonal skill.
- Must possess in-depth legal knowledge to ensure compliance with relevant Health Authority guidelines and regulations.
- Must possess strong analytical and critical thinking skills to identify and address issues related to compliance with urgency.
- Must have the ability to accurately monitor and maintain relevant regulatory information management systems.
- Should have the ability to articulate regulatory requirements and address issues related to compliance with urgency.
- Should have ability to integrate regulatory knowledge into business strategy and achieve regulatory compliance deliverables.
JOB BY
