As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
This role reports to the Head of Regulatory Affairs in the Regulatory Affairs department.
This role is responsible for responsible for ensuring Biopharmaceutical products comply with national and regional regulations. They act as the bridge between the company and regulatory agencies, focusing on obtaining and maintaining product approvals and ensuring compliance throughout the product lifecycle.
This role plays a critical part in ensuring patient safety and the timely market entry of pharmaceutical products in the MENA region, a market characterized by rapid growth and evolving regulatory landscapes
Job Responsibilities
Regulatory Compliance
Ensure adherence to local and regional regulatory requirements across the MENA region, including GCC countries, North Africa, and Levant.
Stay updated with regulatory changes and trends, advising internal teams on potential impacts.
Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Distribution Practices (GDP).
Regulatory Submissions
Prepare, compile, and submit registration dossiers for:
New drugs (Biosimilars).
Variations, renewals, and post-approval changes.
Manage product registrations with national health authorities (e.g., SFDA, MOHAP, EDA).
Product Lifecycle Management
Oversee post-marketing activities, including adverse event reporting, safety updates, and compliance with labeling requirements.
Handle product variations, renewals, and recalls if required.
Liaison with Regulatory Authorities
Build and maintain strong relationships with regulatory bodies across the region (e.g., Saudi FDA, UAE MOH, Egypt Drug Authority).
Represent the company in regulatory discussions, inspections, and audits.
Labeling and Artwork
Review and approve product labeling and packaging to ensure compliance with regional regulations, including Arabic language requirements.
Ensure alignment with marketing and technical documentation.
Cross-functional Collaboration
Work closely with R&D, quality assurance, supply chain, marketing, and legal departments to align on regulatory strategies.
Support market access and pricing teams with regulatory documentation.
Regulatory Intelligence
Monitor and analyze regulatory trends in the MENA region, providing actionable insights to senior management.
Identify opportunities for expedited pathways or alternative regulatory routes.
Required to comply in a manner consistent with company guidelines, compliance SOPs, business ethics, and professional standards.
Responsible to ensure the full application of all local and global SOPs when applicable.
Performs other duties as assigned.
Qualifications
Bachelor’s degree in pharmacy, biotechnology, or a related life sciences field.
Advanced degrees (MBA, MSc) or certifications (e.g., RAC) are advantageous.
5 - 8 years of regulatory affairs experience in the pharmaceutical or healthcare industry.
Experience in MENA-specific regulatory environments is essential.
Prior experience in the healthcare or pharmaceutical industry is preferred.
Skills
Strong understanding of regional regulatory frameworks (e.g., Saudi FDA, GCC Guidelines, EDA).
Familiarity with ICH, WHO, and other global regulatory standards.
Proficiency in preparing Common Technical Document (CTD) submissions.
Proficiency in preparing electronic Common Technical Document (eCTD) submissions.
Excellent communication and negotiation skills for dealing with regulatory authorities.
Detail-oriented with strong organizational and project management abilities.
Ability to work under pressure and manage multiple deadlines.
Strong computer skills in MS Office (insert any other computer skill/program requirements)
Self-motivated and able to work with minimal supervision.
Excellent organizational and problem-solving skills.
Proven ability to adhere to standards & procedures and maintain confidentiality.
Fluency in English is essential.
Proficiency in Arabic is highly desirable for dealing with local authorities.