Pharmaceutical Regulatory Affairs Manager Job Vacancy in Adi Quala, Eritrea – Pharmaceuticals and Healthcare Compliance

Job Description

Position: Pharmaceutical Regulatory Affairs Manager

Company: Novartis International AG

Location: Adi Quala, Eritrea

Experience: Minimum 8 years in pharmaceutical regulatory affairs, with at least 3 years in a managerial role

Education: Master’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or related field

Employment Type: Full-time

Industry: Pharmaceuticals and Healthcare Compliance

Department: Regulatory Affairs

Vacancies:1

Company Overview

Novartis International AG is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. With a rich history of innovation, Novartis is committed to reimagining medicine to improve and extend people’s lives. Our portfolio includes innovative medicines, generics, and biosimilars, reaching hundreds of millions of people globally. In Eritrea, Novartis is dedicated to strengthening the local healthcare ecosystem by ensuring access to high-quality, safe, and effective medicines while building local regulatory and compliance capabilities. We believe in the power of our people and our purpose to create a positive impact on society. This role represents a significant opportunity to contribute to public health in Eritrea by ensuring regulatory excellence and compliance with both national and international standards, thereby supporting the availability of essential medicines for the Eritrean population.

Job Overview

We are seeking a highly experienced and strategic Pharmaceutical Regulatory Affairs Manager to lead our regulatory operations in Eritrea. This pivotal role is based in Adi Quala and is central to our mission of bringing innovative and generic medicines to the Eritrean market in full compliance with the Eritrean Medicines and Food Administration (MFA) and other relevant health authorities. The successful candidate will be the primary point of contact for all regulatory matters, responsible for developing and executing regulatory strategies for product registration, lifecycle management, and compliance. This position offers a unique Career Opportunities in Eritrea within a global pharmaceutical leader, combining local impact with international exposure. You will navigate the complex regulatory landscape, ensuring that Novartis maintains its license to operate while contributing to the health of the nation. For more Jobs in Eritrea and career resources, visit https://eritreajobsearch.com.

Key Responsibilities

• Develop, implement, and manage comprehensive regulatory strategies for the registration, variation, and renewal of pharmaceutical products with the Eritrean MFA.
• Prepare, compile, and submit high-quality regulatory dossiers (e.g., Common Technical Documents – CTD) for new marketing authorizations, line extensions, and post-approval changes.
• Serve as the main liaison between Novartis and the Eritrean regulatory authorities, managing all communications, queries, and inspections.
• Monitor and interpret evolving Eritrean and regional (if applicable) regulatory guidelines, legislation, and trends, advising the business on implications and ensuring proactive compliance.
• Lead the regulatory aspects of product lifecycle management, including labeling updates, safety variations, and renewals.
• Ensure all promotional and non-promotional materials comply with local regulatory and code of practice requirements.
• Manage and mentor a small team of regulatory professionals, fostering a culture of excellence, continuous learning, and accountability.
• Collaborate cross-functionally with Quality Assurance, Pharmacovigilance, Medical Affairs, and Supply Chain teams to ensure integrated regulatory support for all business activities.
• Maintain the company’s regulatory intelligence database and track all submission milestones and approvals.

Required Skills

• Expert knowledge of pharmaceutical regulatory affairs principles, ICH guidelines, and CTD structure.
• In-depth understanding of the Eritrean regulatory environment and submission processes. Knowledge of East African Community (EAC) or other regional frameworks is a plus.
• Proven ability to develop and execute successful regulatory strategies for complex portfolios.
• Excellent project management skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.
• Strong leadership, communication, and interpersonal skills, with the ability to influence stakeholders at all levels.
• High ethical standards and a strong commitment to regulatory compliance and patient safety.
• Strategic thinking and problem-solving abilities.
• Fluency in English and Tigrinya; knowledge of Arabic is advantageous.

Education

A Master’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or a directly related field is required. Additional certifications in Regulatory Affairs (e.g., RAC) are highly desirable. The candidate must demonstrate a continuous learning mindset to keep pace with the dynamic regulatory landscape.

Experience

A minimum of 8 years of progressive experience in regulatory affairs within the pharmaceutical industry is essential. This must include at least 3 years in a managerial or team leadership capacity. Candidates must have a proven track record of successful interactions with health authorities and managing the full lifecycle of regulatory submissions from inception to approval. Experience working in emerging markets, particularly in Africa, will be a significant advantage. This role is a premier example of Employment in Eritrea in the specialized pharmaceutical sector.

Benefits

• Competitive salary and performance-based bonuses aligned with global standards.
• Comprehensive health, life, and disability insurance for employee and family.
• Generous annual leave and public holiday allowance.
• Continuous professional development opportunities and access to global Novartis training programs.
• Contribution to a pension scheme.
• Opportunities for international career mobility within the Novartis network.
• Support for work-life balance initiatives.

Training

• Extensive onboarding program covering Novartis processes, systems, and culture.
• Specialized training in advanced regulatory strategy, leadership, and people management.
• Access to global regulatory conferences and workshops.
• Regular updates on global and local regulatory changes.
• Mentorship from senior regional and global regulatory affairs leaders.

Working Environment

You will be part of a dedicated and professional team in our Adi Quala office, operating within a culture that values integrity, courage, and curiosity. The role involves a mix of independent strategic work and collaborative projects. You will have the resources and autonomy to make a tangible impact on healthcare in Eritrea while being supported by the extensive global network of Novartis. This position represents a key Job Vacancy in Eritrea for professionals seeking meaningful work.

Application Process

Interested and qualified candidates are invited to submit their updated CV and a cover letter detailing their suitability for the role through our official career portal. The selection process will include a preliminary screening, interviews with the hiring manager and regional stakeholders, and potentially a case study presentation. Only shortlisted candidates will be contacted. We are actively Hiring in Eritrea for this critical position. For additional career resources in the region, you may also visit https://www.sudanjobsearch.com/.

Equal Opportunity Statement

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We provide equal Eritrea Jobs opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. We encourage all individuals with the requisite skills and experience to apply for this impactful role in advancing healthcare in Eritrea.