Senior Pharmaceutical Regulatory Affairs Specialist Job Vacancy in Dire Dawa, Ethiopia – Healthcare & Pharmaceuticals

Job Description

Position: Senior Pharmaceutical Regulatory Affairs Specialist

Company: Sanofi Ethiopia

Location: Dire Dawa, Ethiopia

Experience: 5-7 years

Education: Master of Pharmacy or PhD in Regulatory Science

Employment Type: Full-time

Industry: Healthcare & Pharmaceuticals

Department: Regulatory Affairs

Salary: 45,000 – 65,000 SSP

Vacancies: 1

Company Overview

Sanofi is a global leader in healthcare, dedicated to transforming the science to improve people’s lives. As a major player in the pharmaceutical industry, Sanofi focuses on innovative medical solutions for complex diseases. In Ethiopia, we are committed to improving access to essential medicines and ensuring that high-quality healthcare products reach the populations that need them most. Our presence in the region is driven by a mission to bridge the gap between scientific innovation and patient care. We foster a culture of excellence, integrity, and scientific rigor, making us one of the most sought-after employers for professionals seeking meaningful career opportunities in Ethiopia. By joining our team, you become part of a global network of scientists, researchers, and healthcare professionals working toward a healthier future for all.

Job Overview

We are seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Specialist to lead our regulatory compliance strategies in the Dire Dawa region. This role is critical in ensuring that all our pharmaceutical products meet the stringent requirements set by the Ethiopian Food and Drug Authority (EFDA) and other international regulatory bodies. The successful candidate will act as a primary liaison between the company and government health agencies, managing the lifecycle of product registrations, variations, and renewals. This position requires a deep understanding of local and international pharmaceutical laws to ensure seamless market access for our life-saving medications. If you are looking for high-level employment in Ethiopia within the healthcare sector, this role offers unparalleled professional growth. You can find more information about our global mission at https://ethiopiajobssearch.com.

Key Responsibilities

• Lead the preparation and submission of dossiers for new drug applications (NDA) and generic product registrations.
• Monitor changes in local pharmaceutical regulations and ensure company-wide compliance with new EFDA guidelines.
• Manage the lifecycle of existing products, including variations, renewals, and post-approval changes.
• Coordinate with the quality assurance and supply chain teams to ensure all labeling and packaging meet regulatory standards.
• Represent the company during regulatory inspections and audits conducted by national health authorities.
• Provide expert guidance to marketing and sales teams regarding the legal constraints of product claims and advertising.

Required Skills

• Advanced knowledge of ICH guidelines and local Ethiopian pharmaceutical regulatory frameworks.
• Exceptional technical writing skills for dossier preparation and regulatory correspondence.
• Strong analytical skills to interpret complex scientific data and regulatory requirements.
• Excellent negotiation and communication skills for interacting with government officials.
• Project management expertise to handle multiple registration timelines simultaneously.

Education

Candidates must possess a Master of Pharmacy (MPharm) or a PhD in Regulatory Science, Pharmaceutical Sciences, or a closely related field. A strong academic background in medicinal chemistry or pharmacology is highly preferred to ensure technical competence in dossier evaluation.

Experience

A minimum of 5 to 7 years of professional experience in pharmaceutical regulatory affairs is required. Proven experience working with the Ethiopian Food and Drug Authority (EFDA) and a track record of successful product registrations in East Africa is essential. Experience in a multinational pharmaceutical environment is a significant advantage for this vacancy in Ethiopia.

Salary

The monthly salary for this position ranges from 45,000 SSP to 65,000 SSP, depending on the candidate’s expertise and previous experience in the regulatory field.

Benefits

• Comprehensive health and life insurance coverage.
• Performance-based annual bonuses.
• Professional development and certification reimbursement.
• Commuter allowance and wellness programs.

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Training

• Continuous professional development in global regulatory trends.
• Internal leadership and management training programs.
• Specialized workshops on new EFDA compliance protocols.

Working Environment

The working environment is professional, highly structured, and collaborative. While the role is based in our Dire Dawa office, it requires coordination with various international departments. We provide a modern office setting with advanced digital tools to support regulatory documentation and tracking. This is a high-stakes environment where precision and attention to detail are paramount to ensuring patient safety and legal compliance.

Application Process

Interested candidates should submit their updated CV and a cover letter detailing their regulatory experience through our official recruitment portal. We are looking for individuals who demonstrate a passion for healthcare excellence and a commitment to ethical pharmaceutical practices. Please note that only shortlisted candidates will be contacted for interviews. For more career opportunities in Ethiopia, visit https://tanzaniajobsearch.com.

Equal Opportunity Statement

Sanofi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, or disability status.