Regulatory Affairs Manager Job Vacancy in Dessie, Ethiopia – Pharmaceuticals

Job Description

Position: Regulatory Affairs Manager

Company: Bayer Ethiopia

Location: Dessie, Ethiopia

Experience: 5+ years in regulatory affairs within pharmaceutical industry

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

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

Vacancies:1

Company Overview

Bayer Ethiopia is a leading global life‑science company with a strong presence in the Ethiopian market, dedicated to improving health and agriculture through innovative products and sustainable solutions. With a commitment to research, development, and responsible business practices, Bayer supports the growth of the pharmaceutical sector in Ethiopia, fostering local partnerships and contributing to national health objectives. As part of Bayer’s worldwide network, the Dessie office plays a strategic role in ensuring compliance with regional regulations while delivering high‑quality medicines to patients across the country. This position offers a unique opportunity to join a reputable multinational organization that values expertise, integrity, and career development.

Job Overview

The Regulatory Affairs Manager will lead Bayer Ethiopia’s regulatory strategy for product registration, compliance, and market authorization in Ethiopia and neighboring regions. Reporting to the Head of Global Regulatory Affairs, you will collaborate with cross‑functional teams, including research, quality, and marketing, to ensure that all pharmaceutical products meet local and international standards. This role is essential for maintaining Bayer’s reputation for safety and efficacy, supporting the launch of new medicines, and safeguarding existing product lines. For more information about Bayer’s mission and values, visit https://ethiopiajobssearch.com/. This position contributes directly to the broader goal of expanding career opportunities in Ethiopia and strengthening the country’s pharmaceutical landscape.

Key Responsibilities

• Develop and execute regulatory strategies for new product submissions and lifecycle management.
• Prepare, review, and submit dossiers to the Ethiopian Food and Drug Authority (EFDA) and other relevant agencies.
• Maintain up‑to‑date knowledge of local and international regulations, guidelines, and industry best practices.
• Coordinate with R&D, Quality Assurance, and Marketing to ensure alignment of regulatory requirements with product development timelines.
• Lead internal audits and support external inspections to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards.
• Provide regulatory guidance and training to internal stakeholders.
• Monitor post‑marketing surveillance data and manage product labeling updates.
• Represent Bayer Ethiopia in regulatory meetings, workshops, and industry forums.

Required Skills

• Strong understanding of Ethiopian pharmaceutical regulations and international guidelines (e.g., ICH, WHO).
• Excellent written and verbal communication skills in English and Amharic.
• Analytical thinking with the ability to interpret complex scientific data.
• Project management expertise, including timeline and resource coordination.
• Proficiency in regulatory submission software and document management systems.
• Ability to work collaboratively across multidisciplinary teams.

Education

A minimum of a Bachelor’s degree in Pharmacy, Chemistry, Pharmacology, or a related scientific discipline is required. A Master’s degree or professional certification in Regulatory Affairs is highly desirable and will be considered an advantage during the selection process.

Experience

Candidates must have at least five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with a track record of successful product registrations in Ethiopia or comparable emerging markets. Experience with both new drug applications and post‑approval activities is essential.

Salary

The compensation package ranges from SSP 250,000 to SSP 350,000 annually, commensurate with experience and qualifications. The package includes performance‑based incentives, health insurance, and pension contributions.

Benefits

• Comprehensive health and dental coverage.
• Retirement savings plan with employer matching.
• Annual performance bonus.
• Paid parental and sick leave.
• Employee assistance program.

Training

• Access to Bayer’s global learning platform for continuous professional development.
• On‑the‑job training in regulatory intelligence and submission processes.
• Opportunities to attend international conferences and workshops.

Working Environment

Bayer Ethiopia offers a modern, collaborative office environment in Dessie, equipped with state‑of‑the‑art technology and a supportive team culture. Employees benefit from flexible working arrangements, a focus on work‑life balance, and a commitment to diversity and inclusion.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining relevant experience through the online portal on the Bayer Careers website. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment.

Equal Opportunity Statement

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