Operations Officer Jobs

Permanent/Full Time

1 - 3 Years

First Degree

Manufacturing Jobs

Not Specified

EDUCATION/EXPERIENCE • A minimum of a Bachelors Degree in Pharmacy is desirable. • Must have 1-2 years of practical experience in regulatory affairs. • Fluency in the English language is mandatory. REQUIREMENTS • Ability to make timely submissions on post-approval changes and follow up for endorsement. • 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 be attentive to details to monitor and maintain relevant regulatory information management systems. • Ability to articulate regulatory requirements and address issues related to compliance with urgency. • Ability to integrate regulatory knowledge into business strategy and achieve 95% regulatory compliance deliverables.

2024-11-01

Our client, a leading pharmaceutical company is search for a proactive and experienced individual with effective communication abilities to provide administrative support to regulatory staff as a Regulatory Affairs Associate.

 

ROLE PROFILE

The qualified individual will be accountable for maintaining all necessary regulatory databases such as DRAGON to ensure regulatory compliance. The expert will be supporting other regulatory affairs managers by maintaining open communication with internal stakeholders such as NCO, CMC and regulatory affairs team while providing feedback. The selected candidate will follow up with health authorities, achieving conclusions of submitted applications and escalating issues where necessary. These duties will be carried out well including the following;

 

DUTIES AND RESPONSIBILITIES

• Prepare applications and confirm submissions for post-approval changes are made and follow up with the Health Authority for timely approval.


• Maintain adherence to global, local and regional processes for life-cycle maintenance activities.


• Review the health authorities' website regularly and ensure current information and updated guidelines are shared with the Regulatory Authority team and relevant databases are accurate.


• Develop and maintain good work relationships with Health Authorities and provide feedback from Health Authorities about submissions made.


• Ensure matters of non-compliance are managed urgently and the right channel is used promptly.


• Appropriately share any identified matters related to compliance and regulatory intelligence that affect the life cycle management.


• Assist regulatory affairs projects and activities as assigned by the regulatory affairs managers.

Accra Central

Greater Accra

1st Otwe Street