Job Description
Position: Senior Pharmaceutical Regulatory Affairs Specialist
Company: Novartis Eritrea
Location: Barentu, Eritrea
Experience: 7+ years
Education: Master of Pharmacy or PhD in Regulatory Science
Employment Type: Full-time
Industry: Healthcare & Life Sciences
Department: Regulatory Affairs
Salary: 45,000 – 65,000 SSP
Vacancies: 1
Company Overview
Novartis is a global leader in healthcare, dedicated to transforming medicine through innovative science and cutting-edge technology. Our mission is to reimagine medicine to improve and extend people’s lives. In Eritrea, we are expanding our footprint to ensure that high-quality pharmaceutical solutions reach diverse populations. We pride ourselves on a culture of curiosity, collaboration, and integrity. As we grow our presence in the region, we are looking for top-tier professionals to join our mission of excellence. We offer a dynamic environment where scientific breakthroughs lead to real-world impact. For those seeking Eritrea Jobs, our organization represents the pinnacle of pharmaceutical innovation and professional growth.
Job Overview
The Senior Pharmaceutical Regulatory Affairs Specialist will play a critical role in ensuring that all our medical products comply with local and international regulatory standards. This position is vital for our operations in Barentu, acting as the primary liaison between the company and national health authorities. You will oversee the submission of dossiers, manage product registrations, and ensure that all marketing activities align with legal requirements. This is a high-impact role that requires a deep understanding of pharmaceutical law and a commitment to patient safety. If you are looking for Career Opportunities in Eritrea, this role offers unparalleled exposure to international regulatory frameworks and complex compliance landscapes.
Key Responsibilities
- Lead the preparation and submission of comprehensive regulatory dossiers for new drug applications.
- Maintain and update existing product licenses to ensure continuous compliance with evolving local laws.
- Collaborate with the Quality Assurance team to monitor post-market surveillance and safety reporting.
- Act as the primary point of contact for the Ministry of Health and other regulatory bodies.
- Review promotional materials to ensure all claims are scientifically substantiated and legally compliant.
- Provide expert guidance to the marketing and supply chain teams regarding regulatory constraints.
Required Skills
- Expert knowledge of ICH (International Council for Harmonisation) guidelines.
- Exceptional analytical skills with high attention to detail in technical documentation.
- Strong communication skills for negotiating with government officials and internal stakeholders.
- Advanced project management capabilities to handle multiple registration timelines simultaneously.
- Proficiency in regulatory information management systems (RIMS).
Education
A minimum of a Master of Pharmacy (M.Pharm) or a PhD in Regulatory Science, Pharmacology, or a related life sciences field is mandatory. Advanced certification in Regulatory Affairs is highly preferred.
Experience
Candidates must possess at least 7 years of progressive experience in pharmaceutical regulatory affairs, with a proven track record of successful product registrations in East African markets. Experience working within a multinational pharmaceutical environment is essential for this role.
Salary
The offered salary for this position is between 45,000 SSP and 65,000 SSP per month, depending on experience and qualifications. This is a competitive package designed to attract the best talent in the industry.
Benefits
- Comprehensive health and dental insurance coverage.
- Performance-based annual bonuses.
- Generous paid time off and parental leave.
- Subsidized wellness and gym memberships.
- Professional development and tuition reimbursement programs.
Training
- Continuous professional development workshops on global regulatory updates.
- Internal leadership and management training programs.
- Specialized technical training on new pharmaceutical technologies.
Working Environment
This is a professional office-based role located in Barentu, with occasional travel to regional health offices. We foster a collaborative and inclusive environment where diversity is celebrated. We are committed to providing Employment in Eritrea that supports work-life balance and professional excellence. Our office is equipped with modern technology to facilitate seamless communication with our global headquarters.
Application Process
Interested candidates should submit their CV and a cover letter detailing their regulatory experience through our official portal. We are currently Hiring in Eritrea and look forward to reviewing your application. Please note that only shortlisted candidates will be contacted for an interview. This is a unique Job Vacancy in Eritrea for a highly qualified professional.
Equal Opportunity Statement
Novartis is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business needs, without regard to race, religion, color, national origin, gender, sexual orientation, age, or disability status. We encourage all qualified applicants to apply for Jobs in Eritrea.