Job Openings
Company Info
- 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.
- For more information, please visit www.fresenius-kabi.com
Position Summary
- 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.
Position Summary
- This role reports to the Sales Manager in the Sales department
- This role is based in Dubai, UAE
- This role is responsible for promoting Fresenius Kabi products to hospitals, medical centers, and pharmacies through direct interactions and presentations. It involves building strong customer relationships, driving sales growth, and supporting the company’s market position
- The position requires effective communication, adherence to company policies, and maintaining a professional image.
Job Responsibilities
- Promote Fresenius Kabi products to target customers in hospitals, medical centers and pharmacies.
- Achieve promotion through face-to-face calls, group presentations and other promotional techniques.
- Establish and maintain strong relationships with current and prospective customers.
- Maintain a high image for Fresenius Kabi as a market leader in clinical nutrition and I.V. generics.
- Seek and create market opportunities to increase target sales.
- Maintain the confidentiality of all Fresenius Kabi tenders.
- Implement all approved marketing strategies and action plans.
- Monitor stocks and the rate of consumption of Fresenius Kabi products and competitor products in his/her accounts.
- Continuously update product knowledge through various available materials.
- Report marketing and sales feedback on a continuous basis to his/her line manager.
- Update customer database regularly.
- Present a professional image at all times (way of dress, relationships with customers, etc.).
- Follow all company policies, norms and rules.
- Use company properties and resources properly.
- Establish good relationships with all employees of all levels in the company.
Calls & Promotional Activities:
Ensure the quality of calls:
o Handle 100% of questions related to the product.
o Handle at least 90% of objections.
o Handle promotional materials correctly.
o Handle giveaways correctly.
o Be fully aware of major competitors of our products.
Report activities:
o Submit a daily report for normal activities.
o Submit a monthly report for sales progress, events and developments affecting sales within the area of responsibility.
Follow up on sales:
o Ensure the delivery of orders from distributors to different customers on time.
o Contact and follow up with distributors’ sales team regarding the coverage plan at least once every 2 weeks.
o Check stock levels of Fresenius Kabi products and their expiry dates in different hospitals at least once every 2 weeks.
Meetings & Company’s Training Programs/Courses:
o Actively participate in all meetings.
o Communicate openly during meetings with colleagues and managers.
Additional responsibilities
- Ensure compliance with company guidelines, corporate policies, ethical standards, and all applicable local and global SOPs and professional standards.
- Safeguard company assets and follow the compliance policy to ensure all operations are in line with legal and regulatory requirements.
- Report Adverse Drug Reactions (ADRs) and Complaints about Fresenius Kabi’s products from Market Unit MENA to the responsible function, immediately after receipt, but latest within 1 business day.
- Performs other duties as assigned.
Skills & Competencies
- Excellent communication skills in verbal and writing.
- Good negotiations skills to deal with Medical and Healthcare Professionals.
- Effective time management, organization and multitasking skills.
- Confidence, persistence, patience, self-motivation, and team player.
Requirements
- Bilingual (English and Arabic) is a must
- Pharmacy/Medical/Scientific Background
- Proficient in MS Office
- UAE Driving License
- Job Type: Full-time
- Experience:1 to 3 years in UAE in pharmaceutical sales