Regulatory Affairs Specialist Job Vacancy in Zalambessa, Eritrea – Pharmaceuticals
Job Description
Position:Regulatory Affairs Specialist
Company:Novartis AG
Location:Zalambessa, Eritrea
Experience:3-5 years in regulatory affairs within the pharmaceutical industry
Education:Bachelor’s degree in Pharmacy, Life Sciences, or a related field
Employment Type:Full-time
Industry:Pharmaceuticals
Department:Regulatory Affairs
Salary:150,000 SSP – 250,000 SSP per month
Vacancies:1
Company Overview
Novartis AG is a global leader in innovative medicines, dedicated to improving health outcomes worldwide. With a strong commitment to research, development, and responsible business practices, Novartis operates in more than 150 countries, delivering cutting‑edge therapies across therapeutic areas. In Eritrea, Novartis has established partnerships with local health authorities and distributors to ensure access to high‑quality medicines. The company’s presence in the region reflects its strategic focus on emerging markets, fostering sustainable growth while adhering to the highest standards of compliance and ethical conduct. As part of its mission, Novartis invests in local talent, offering career pathways that empower professionals to contribute to global health initiatives and drive meaningful change in the community.
Job Overview
The Regulatory Affairs Specialist will play a pivotal role in ensuring that all Novartis products marketed in Eritrea meet the regulatory requirements set by the Ministry of Health and other relevant authorities. This position involves preparing, reviewing, and submitting regulatory dossiers, maintaining product registrations, and acting as a liaison between internal teams and external regulatory bodies. The specialist will also monitor changes in legislation, provide strategic guidance on compliance, and support cross‑functional projects to facilitate timely product launches. This role offers a unique opportunity to work within a multinational environment while contributing directly to the health and well‑being of the Eritrean population.
Key Responsibilities
- Prepare and submit comprehensive regulatory dossiers for new product registrations and variations.
- Maintain and update existing product registrations to ensure ongoing compliance.
- Monitor Eritrean pharmaceutical regulations and advise internal stakeholders on implications.
- Coordinate with quality, clinical, and marketing teams to gather required documentation.
- Act as the primary point of contact with the Ministry of Health and other regulatory agencies.
- Develop and implement regulatory strategies to support product lifecycle management.
- Provide training to internal staff on regulatory requirements and best practices.
- Assist in the preparation of risk management plans and safety reports.
Required Skills
- In‑depth knowledge of Eritrean pharmaceutical regulations and international guidelines (e.g., ICH, WHO).
- Strong analytical and problem‑solving abilities.
- Excellent written and verbal communication skills in English and Arabic.
- Proficiency in regulatory submission software and document management systems.
- Ability to work collaboratively across multidisciplinary teams.
- Attention to detail and high level of organizational skills.
Education
A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced degrees or certifications in regulatory affairs (e.g., RAC, RAPS) are highly desirable and will be considered an advantage during the selection process.
Experience
Candidates must have a minimum of three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to emerging markets. Experience in preparing dossiers for product registration, variation, and renewal in compliance with local and international standards is essential.
Salary
The position offers a competitive salary range of 150,000 SSP to 250,000 SSP per month, commensurate with experience and qualifications. Performance‑based incentives and annual reviews are part of the compensation package.
Benefits
- Comprehensive health insurance covering employee and dependents.
- Retirement savings plan with employer contributions.
- Paid annual leave and public holidays in accordance with Eritrean labor law.
- Professional development allowance for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering Novartis policies, compliance, and local regulatory landscape.
- Continuous learning opportunities through internal e‑learning platforms.
- Mentorship from senior regulatory professionals.
- Access to global regulatory workshops and webinars.
Working Environment
Novartis provides a dynamic, inclusive, and collaborative workplace that encourages innovation and personal growth. The Zalambessa office is equipped with modern facilities, offering a safe and supportive environment for all employees. Team members benefit from open communication channels, regular feedback, and a culture that values diversity and respect. https://lesothojobsearch.com/
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment. For further details on the recruitment timeline, please refer to the official Novartis careers page. https://tanzaniajobsearch.com/job-vacancy-tanzania/
Equal Opportunity Statement
Novartis is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, gender, age, religion, disability, sexual orientation, or any other protected characteristic. All qualified applicants will receive consideration for employment without discrimination.
