Senior Officer: Regulatory Affairs and QPPV Backup - DKT International

DKT International Inc. is a non-profit organization whose mission is to provide safe and affordable options for family planning and HIV/AIDS prevention. DKT operates 24 programs across 25 countries worldwide, contributing to improved reproductive health and social marketing initiatives.

Job Description

• Department:  Regulatory Affairs and Pharmacovigilance 
• Organization Relationship 
• Directly reports to:  Manager - Regulatory Affairs and QPPV 
• Directly supervises: N/A 

Job Summary 

The Senior Officer – Regulatory Affairs and Qualified Person for Pharmacovigilance (QPPV) Backup will work closely with the Manager – Regulatory Affairs and QPPV and is accountable in the absence of the QPPV for the preparation and management of simple and complex regulatory submissions. Act as a backup on all matters relating to pharmacovigilance and safety of the marketed products including pharmacovigilance inspections.

Assist in establishing and maintaining a system which ensures information about all suspected adverse drug reaction/event which are reported to the personnel of the marketing authorization holder, including to medical representatives, is collected, processed and evaluated and forwarded to the Authority in line with the timelines stipulated by the authority. 

The incumbent will work independently and within a group setting to act as a liaison between Regulatory Affairs and other functional areas including external regulatory bodies, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to government regulatory agencies in the absence of the Manager - Regulatory Affairs and QPPV. 

Specific Duties and Responsibilities

Under the supervision of the Manager – Regulatory Affairs and QPPV, the Senior Officer will:

• Assist in the development and implementation of regulatory strategies and ensure compliance with national regulatory requirements.
• Support the registration of new products and timely renewal of existing licenses with the Food and Drugs Authority (FDA).
• Compile, coordinate, and maintain regulatory documentation (e.g., safety reports, annual reports, PSURs, DSURs) in line with applicable regulations.
• Maintain regulatory files, databases, and document control systems to ensure data integrity and traceability.
• Support the preparation and submission of:

1. • Individual Case Safety Reports (ICSRs)
   • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
   • Risk Management Plans (including Ghana-specific RMPs)
   • Clinical and post-marketing study reports as required by authorities

• In the absence of the QPPV, ensure timely response to regulatory queries and requests for safety data or risk–benefit evaluations.
• Contribute to safety surveillance activities, including monitoring and evaluating product safety signals and emerging risks.
• Participate in the review of promotional materials and product information to ensure compliance with regulatory and pharmacovigilance requirements.
• Provide oversight of pharmacovigilance systems, including adverse event reporting, case follow-up, and submission tracking.
• Coordinate regulatory actions in response to emerging safety concerns (e.g., variations, urgent safety restrictions, communications to healthcare professionals).
• Ensure accurate record-keeping of interactions with regulatory authorities, manufacturers, and suppliers.

Required Skills or Experience

Preferred Qualifications

• Bachelor’s degree in the sciences or a related field.
• Experience in regulatory affairs and/or pharmacovigilance is preferable
• Familiarity with WHO, ICH, and local FDA guidelines for regulatory and PV compliance. 
• QPPV qualification will be an added advantage

Core Competencies and Abilities

• Proven experience in regulatory submissions, including marketing authorization applications in Common Technical Document (CTD) format.
• Strong understanding of Ghana FDA and GSA regulatory requirements.
• Ability to prioritize multiple assignments, exercise good judgment, and meet tight deadlines.
• Excellent communication and interpersonal skills, with the ability to collaborate across departments and influence stakeholders.
• Analytical mindset with attention to detail and high standards of documentation accuracy.
• Proficiency in Microsoft Office Suite, Adobe Acrobat, and Excel; knowledge of regulatory databases is an advantage.
• High integrity, organizational commitment, and ability to work both independently and as part of a team.

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