Regulatory Affairs Manager Job Vacancy in Harar, Ethiopia – Pharmaceuticals

Job Description

Position:Regulatory Affairs Manager

Company:Johnson & Johnson Ethiopia

Location:Harar, Ethiopia

Experience:5+ years in pharmaceutical regulatory affairs

Education:Bachelor’s degree in Pharmacy, Chemistry or related field; Master’s preferred

Employment Type:Full-time

Industry:Pharmaceuticals

Department:Regulatory Affairs

Salary:250,000 – 350,000 SSP per month

Vacancies:1

Company Overview

Johnson & Johnson Ethiopia is a leading multinational healthcare company dedicated to improving the health and well‑being of people across the nation. With a legacy of more than 130 years, the company operates in consumer health, medical devices, and pharmaceuticals, delivering innovative products that meet the highest standards of safety and efficacy. In Ethiopia, J&J collaborates with local distributors, government agencies, and research institutions to ensure that life‑saving medicines reach every corner of the country. The Harar office serves as a strategic hub for regulatory, quality, and market access activities, supporting the company’s mission to bring advanced healthcare solutions to the Ethiopian market. This presence creates a vibrant environment for professionals seeking to contribute to global health while working locally.

Job Overview

The Regulatory Affairs Manager will lead the development, implementation, and maintenance of regulatory strategies for all pharmaceutical products marketed or planned for launch in Ethiopia. Reporting to the Regional Head of Regulatory Affairs, the incumbent will act as the primary liaison between Johnson & Johnson Ethiopia and the Ethiopian Food and Drug Authority (EFDA). The role involves ensuring compliance with local regulations, preparing and submitting dossiers, and providing strategic guidance to cross‑functional teams. This position is critical for safeguarding product integrity, accelerating time‑to‑market, and supporting the company’s growth objectives in the Ethiopian pharmaceutical sector. The role also contributes to broader corporate goals of ethical conduct, patient safety, and sustainable business practices.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations, variations, and renewals in Ethiopia.
• Prepare, review, and submit comprehensive dossiers, including CTDs, INDs, and post‑approval variations, to the EFDA.
• Maintain up‑to‑date knowledge of Ethiopian pharmaceutical regulations, guidelines, and international standards such as ICH and WHO.
• Provide regulatory guidance to R&D, manufacturing, marketing, and legal teams throughout the product lifecycle.
• Lead interactions with the EFDA, including meetings, inspections, and audits, ensuring transparent communication and timely resolution of queries.
• Monitor and assess regulatory changes, advising senior management on potential impact and required actions.
• Develop and maintain a centralized regulatory information database for all products.
• Support pharmacovigilance activities by ensuring adverse event reporting complies with local requirements.
• Collaborate with regional regulatory colleagues to harmonize strategies across East Africa.
• Prepare internal training materials and conduct workshops on regulatory best practices.

Required Skills

• Deep understanding of Ethiopian pharmaceutical law, EFDA processes, and international regulatory frameworks.
• Excellent written and verbal communication skills in English; proficiency in Amharic or Afaan Oromo is a plus.
• Strong analytical and problem‑solving abilities, with attention to detail.
• Proven project management skills, capable of handling multiple dossiers simultaneously.
• Ability to influence cross‑functional teams and negotiate with external authorities.
• High ethical standards and commitment to patient safety.

Education

A bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. A master’s degree or professional certification (e.g., RAC, RAPS) is highly desirable and demonstrates a commitment to regulatory excellence.

Experience

Minimum of five years of progressive experience in regulatory affairs within the pharmaceutical industry, preferably with direct exposure to Ethiopian or East African markets. Experience in managing full product life‑cycle submissions and leading regulatory interactions with health authorities is essential.

Salary

The competitive salary range for this role is 250,000 – 350,000 SSP per month, commensurate with experience and qualifications. Performance‑based incentives and annual bonuses are part of the total compensation package.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Paid annual leave, sick leave, and public holidays in accordance with Ethiopian labor law.
• Professional development allowance for certifications, conferences, and training.
• Employee assistance program and wellness initiatives.

Training

• Onboarding program covering J&J’s global regulatory policies and local compliance requirements.
• Continuous learning opportunities through internal e‑learning platforms and external workshops.
• Mentorship from senior regulatory leaders across the Johnson & Johnson network.

Working Environment

The Harar office offers a modern, collaborative workspace equipped with state‑of‑the‑art technology and meeting rooms designed for cross‑functional teamwork. Employees enjoy a culture that values diversity, inclusion, and innovation. Flexible working arrangements, including occasional remote work, are supported to promote work‑life balance.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through our online portal. Applications will be reviewed on a rolling basis until the position is filled. For more information about the role and to apply, please visit our main website https://ethiopiajobssearch.com. Additional resources about working in Ethiopia can be found at https://www.zimbabwejobsearch.com/.

Equal Opportunity Statement

Johnson & Johnson Ethiopia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, religion, gender, sexual orientation, age, disability, or veteran status. All qualified applicants will receive consideration for employment without discrimination.