Pharmaceutical Regulatory Compliance Manager Job Vacancy in Adi Quala, Eritrea – Pharmaceutical Manufacturing and Quality Assurance

Job Description

Position: Pharmaceutical Regulatory Compliance Manager

Company: Novartis International AG

Location: Adi Quala, Eritrea

Experience: Minimum 7-10 years in pharmaceutical regulatory affairs, quality assurance, or compliance, with at least 3 years in a managerial role. Experience in African or emerging markets is highly desirable.

Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific field. A Master’s degree in Regulatory Affairs, Quality Assurance, or Business Administration is a strong advantage. Professional certifications (e.g., RAC) are preferred.

Employment Type: Full-time

Industry: Pharmaceutical Manufacturing and Quality Assurance

Department: Regulatory Affairs and Quality Compliance

Vacancies:1

Company Overview

Novartis International AG is a global healthcare leader headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people’s lives. With a robust portfolio of innovative medicines, generics, and biosimilars, Novartis reaches patients in over 140 countries. Our mission is to discover new ways to treat and cure disease. In Eritrea, Novartis is committed to strengthening local healthcare systems, ensuring access to high-quality, safe, and effective medicines, and building local capacity in pharmaceutical sciences. This role is pivotal in establishing and maintaining the highest standards of regulatory compliance for our operations and product portfolio within the Eritrean market and supporting regional regulatory strategies. We offer a dynamic, science-driven environment where professionals can make a tangible impact on public health.

Job Overview

We are seeking a highly experienced and detail-oriented Pharmaceutical Regulatory Compliance Manager to lead our regulatory and quality assurance efforts in Eritrea. This senior role is responsible for ensuring all Novartis products meet stringent local and international regulatory requirements, managing submissions to the Eritrean Medicines and Food Administration (MFA), and overseeing a robust quality management system. The successful candidate will be the primary point of contact for all regulatory bodies, driving compliance strategies, and mitigating risks to ensure uninterrupted supply of essential medicines. This position offers a unique opportunity to shape the regulatory landscape, contribute to public health outcomes, and advance your career with a world-leading pharmaceutical company. For more Jobs in Eritrea and Career Opportunities in Eritrea, visit our partner portal at https://eritreajobsearch.com.

Key Responsibilities

• Develop, implement, and manage comprehensive regulatory strategies for product registrations, renewals, and variations in compliance with Eritrean MFA and relevant international standards (WHO, ICH, FDA, EMA).
• Prepare, compile, and submit high-quality regulatory dossiers (CTD format), ensuring accuracy, completeness, and timely approval.
• Serve as the official liaison with the Eritrean MFA and other health authorities, managing all communications, queries, and inspections.
• Establish and maintain the site’s Quality Management System (QMS), including SOPs, change control, deviations, CAPA, and management review.
• Lead internal and external audits, ensuring readiness for regulatory inspections and driving continuous improvement in compliance processes.
• Monitor and interpret evolving regulatory guidelines and legislation in Eritrea and the East African region, advising internal stakeholders on impact and required actions.
• Manage product lifecycle activities, including labeling updates, safety reporting compliance, and post-marketing surveillance requirements.
• Train and mentor local staff on Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and regulatory requirements.
• Collaborate with regional and global regulatory teams to align Eritrea operations with corporate standards and strategies.
• Manage regulatory documentation and archives in accordance with data integrity principles.

Required Skills

• Expert knowledge of pharmaceutical regulatory affairs, drug development, and registration processes in Africa, with specific familiarity with Eritrean regulations being a major asset.
• In-depth understanding of ICH guidelines, GxP (GMP, GLP, GDP) requirements, and quality systems.
• Proven project management skills with the ability to manage multiple complex submissions and deadlines simultaneously.
• Excellent analytical, problem-solving, and decision-making abilities with a strong risk-based approach.
• Outstanding communication, negotiation, and interpersonal skills for effective interaction with health authorities and cross-functional teams.
• High ethical standards and integrity with a commitment to patient safety and product quality.
• Leadership capabilities to build, develop, and motivate a high-performing compliance-oriented team.
• Proficiency in regulatory information management systems and MS Office applications.
• Fluency in English and Tigrinya; knowledge of Arabic is beneficial.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a closely related scientific discipline is mandatory. An advanced degree (Master’s or PhD) in Regulatory Affairs, Quality Assurance, or Business Administration is highly preferred and will be given significant consideration. Professional certifications such as Regulatory Affairs Certification (RAC) are a strong advantage and demonstrate a committed expertise to the field. Continuous professional development in regulatory science is expected.

Experience

A minimum of 7-10 years of progressive experience in pharmaceutical regulatory affairs, quality assurance, or compliance within a multinational corporation or a stringent regulatory environment is required. At least 3 years must be in a managerial or team leadership capacity, demonstrating experience in guiding regulatory strategy and managing people. Direct hands-on experience with dossier preparation and submissions to African national regulatory authorities is essential. Experience in managing regulatory inspections and audits is critical. A background in both innovative and generic medicines is valuable. This Job Vacancy in Eritrea represents a key leadership position for a seasoned professional.

Benefits

• Competitive, tax-advantaged salary package commensurate with experience and global Novartis standards.
• Comprehensive international health, dental, and life insurance coverage for employee and family.
• Performance-based annual bonus and long-term incentive plans.
• Generous paid time off, including annual leave, sick leave, and public holidays.
• Robust pension plan and savings schemes.
• Continuous professional development budget for conferences, courses, and certifications.
• Relocation assistance (if applicable) and housing allowance.
• Access to global Novartis employee networks and well-being programs.

Training

• Extensive onboarding program covering Novartis values, compliance culture, and internal systems.
• Specialized training in advanced regulatory strategy, dossier writing, and negotiation skills.
• Leadership and management development programs offered through the Novartis Global Learning Institute.
• Regular updates on global regulatory trends, pharmacovigilance, and quality management systems.
• Opportunities for short-term international assignments and secondments within the Novartis network.

Working Environment

You will work in a modern, well-equipped office and compliance facility in Adi Quala, collaborating with a dedicated local team and connecting daily with regional and global colleagues. The role demands a high level of autonomy and strategic thinking, balanced with meticulous attention to detail. The pace is fast and dynamic, responding to both business needs and regulatory changes. Novartis fosters a culture of innovation, integrity, and inclusion, where your expertise will be valued and your contributions will directly impact patient health in Eritrea. We support flexible working arrangements where operationally feasible.

Application Process

Interested and qualified candidates are invited to submit their updated CV and a cover letter detailing their relevant experience and motivation for this role through the official Novartis careers portal. The recruitment process will involve an initial screening, followed by interviews with the Regional Regulatory Head and local Country Manager, and potentially a case study presentation. We encourage all eligible professionals seeking Employment in Eritrea in the pharmaceutical sector to apply. For a broader view of Hiring in Eritrea and the region, you may also consult 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 employment opportunities to all applicants and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by local law. We are proud to be a partner in advancing Eritrea Jobs and building local expertise in the healthcare sector.