Fella KACI
Regulatory Affairs Expert | Pharmaceutical & Biotechnology Industry
Dubai
Summary
Results-driven pharmaceutical and biotechnology leader with 15+ years of global experience spanning regulatory affairs, strategic planning, and data analytics across three continents. Proven track record in navigating complex regulatory landscapes and accelerating market access in osteoporosis, nephrology, cardiovascular, CNS, metabolic disorders, immunology, oncology, and hematology. ️ Regulatory strategist with expertise in market entry, compliance, and lifecycle management. ️ Data-driven decision-maker, optimizing regulatory pathways through analytics and insights. ️ Business-focused collaborator, aligning regulatory objectives with commercial success. ️ Trilingual (English, Arabic & French) with deep cross-cultural expertise in global regulatory frameworks.
Overview
12
12
years of professional experience
10
10
years of post-secondary education
3
3
Languages
Work History
Founder & Regulatory Affairs Consultant
Apotekon
01.2025 - Current
- Founded Apotekon, a regulatory affairs consultancy specializing in the pharmaceutical industry across the Middle East & Africa (MEA) region
- Expert in fast-track file preparation, ensuring efficient dossier compilation, submission, and regulatory approval to accelerate market access
- Provide strategic regulatory guidance to streamline dossier preparation, accelerate market access, and ensure compliance with regional regulations
- Developed structured regulatory strategies, optimizing registration timelines, compliance processes, and risk mitigation for pharmaceutical companies
- Created standardized dossier preparation frameworks, enhancing efficiency, accuracy, and compliance with MEA regulatory requirements
- Monitor evolving regulatory landscape, proactively addressing compliance challenges and supporting clients in navigating complex registration processes
Regulatory Affairs General Manager – MENAT FWA PA Region
Emcure Pharmaceuticals Limited
08.2019 - 02.2024
- Led and coached the regulatory team to ensure strong development
- Set the regulatory strategy and ensure proper implementation
- Align the regulatory department objectives with commercial in order to achieve the budget
- Acted as a regulatory expert and advisor to the SVP for business negotiations with partners
- Supported new market entries
- Fostered cross-functional collaboration to maximize business opportunities
Senior Regulatory Affairs Manager - MEA Region
NewBridge Pharmaceuticals
10.2016 - 08.2019
- Headed the regulatory business unit, leading a team of 4 professionals
- Managed regulatory affairs for over 37 SKUs across five business units (Immunology, CNS, General Medicine & Metabolic care, Oncology & Oncology palliative and orphan disease)
- Developed and implemented regulatory strategies across 15 countries in coordination with business partners and management team
- Provided regulatory consultancy for 7+ global pharmaceutical companies: Kyowa Kirin International, UCB, Sunovion, Eisai, Intercept, Abiogen, & Eusa & more
- Provide regulatory intelligence and act as the regulatory interface to all product brand teams to ensure requirements and timelines are incorporated into the product launch process
- Acted as a regulatory advisor to the board for deal negotiations
- Conducted pricing and regulatory analysis for new markets and new products
- Ensured regulatory compliance for product launches
- Managed department data reporting, compliance tracking, and analysis to align with business objectives and filing goals on a monthly and annual basis
- Established partnerships with 28+ local distributors in the MEA region
- Awarded Best Regulatory Representative 2018
Regulatory Affairs Manager - MEA Region
Amgen
01.2014 - 10.2016
- Company Overview: Dubai
- Managed 40+ MAH transfer licenses from preparation to approval
- Provided regulatory input for global strategy decisions and regional insights to drive regulatory strategies
- Reviewed and approved 1000+ medical and promotional materials for the MEA region
- Designed and implemented a review and approval process for promotional and non-promotional material according to company policy, local country guidelines and pharmaceutical association’s code of conduct (MEA code)
- Managed the department budget
- Trained and coached new hires
- Acted as department main back-up
- Reviewed & approved 100+ source texts for regional labeling needs
- Led Amgen MEA Regulatory Seminars in 2014 & 2015, attended by key stakeholders
- Dubai
- Nominated as Top Performer among AMGEN Middle East and Africa Employees in 2015-2016
Sr Associate Marketing Nephrology & Bone - MEA Region
Amgen
04.2013 - 12.2013
- Developed regional marketing strategies
- Conducted competitive landscape analysis.
- Managed all promotional materials.
- Organized the Amgen Regional Hospital Pharmacist Forum with 100+ attendees.
Education
Ph.D. - Thesis Title: "Biosimilars Landscape in MEA"
Paris Saclay
Paris, France 01.2024 - 12.2024
Master of Science - Regulatory affairs and Marketing, Medicines and other healthcare products
Paris Saclay
Paris, France 01.2012 - 01.2013
Doctor of Pharmacy - Pharmacy
Paris Saclay
Paris, France 09.2005 - 09.2013
Skills
- Regulatory Affairs
- Regional Filing Strategy
- Regulatory Intelligence
- Biologics & Biosimilars
- Pricing Regulations
- Distributor and Partners Management
- Promotional & Non-Promotional Activities
- SOPs and Process Development
Data Analytics
Websites
Timeline
Founder & Regulatory Affairs Consultant
Apotekon
01.2025 - Current
Ph.D. - Thesis Title: "Biosimilars Landscape in MEA"
Paris Saclay
01.2024 - 12.2024
Regulatory Affairs General Manager – MENAT FWA PA Region
Emcure Pharmaceuticals Limited
08.2019 - 02.2024
Senior Regulatory Affairs Manager - MEA Region
NewBridge Pharmaceuticals
10.2016 - 08.2019
Regulatory Affairs Manager - MEA Region
Amgen
01.2014 - 10.2016
Sr Associate Marketing Nephrology & Bone - MEA Region
Amgen
04.2013 - 12.2013
Master of Science - Regulatory affairs and Marketing, Medicines and other healthcare products
Paris Saclay
01.2012 - 01.2013
Doctor of Pharmacy - Pharmacy
Paris Saclay
09.2005 - 09.2013
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