DALIA ELGABARTY (MBA, PM)

As a passionate Regional Pharmaceutical Regulatory Affairs Director, I bring over 15 years of expertise in navigating complex regulatory frameworks, ensuring compliance and advancing innovative healthcare solutions. I have a proven track record in developing and executing regulatory strategies and registering various therapeutic portfolios, contributing to the advancement of the pharmaceutical industry

(002)-01028888098, (002)-01223178019

Emerging Markets Regional Regulatory Affairs Strategy Director (Regional Hub team lead), Pfizer Biopharmaceuticals Group, Cairo, Egypt, 01/01/22, 02/01/24, 

Develop and implement regulatory strategies, ensuring timely submission and approval of all necessary documentation for the registration and maintenance of pharmaceutical products.

· Lead a high-performing team of regulatory affairs professionals to ensure compliance with regional and international regulations, standards, and guidelines.

· Collaborate with cross-functional teams to provide regulatory guidance and support for the growth of new products, including conducting risk assessments and evaluating regulatory requirements.

· Skilled with guidelines and regulations, attentiveness to the reliance on the EU and FDA, and strong knowledge of ICH guideline interpretation and implementation.

· Spearheaded initiatives to monitor and anticipate changes in regulatory requirements in emerging markets, proactively adapting strategies to maximise opportunities and compliance.

· Conduct in-depth regulatory assessments and provide expert guidance in regulatory strategy development.

· Establish and maintain strong relationships with regulatory authorities, industry associations, and external stakeholders in the region to proactively address regulatory issues and streamline processes.

· Conduct internal audits and develop corrective action plans to address regulatory compliance gaps, ensuring adherence to quality standards and regulations.

· Stay abreast of emerging regulatory trends and developments, actively participating in industry conferences and professional networks to drive knowledge sharing and continuous advancement within the regulatory affairs team.

· Demonstrated exemplary project management acumen by successfully steering multiple complex projects concurrently, ensuring timely deliverables within allocated budgets, and maintaining impeccable quality standards.

Key Achievements:

· Successfully obtained regulatory approvals for pivotal products in various therapeutic areas, playing a key role in market success.

· Oversaw the regulatory team in achieving specific milestones, e.g., expedited approval of newly acquired molecules across the region for critical products.

· Implemented strategic initiatives resulting in enhanced regulatory capabilities and team performance.

· Successfully led different global projects specifically for EM, e.g., EM portfolio optimisation, local manufacturing CMC gap closure , and local manufacturing interim processes, for the support of the regional \ global team.

· EM business development (acquisition/integration) playbook as part of strategy process optimisation. to provide a roadmap for strategy and submission planning in alignment with regulatory guidelines per market.

· Oversaw the Global Women Health Care Project GHI, a WHO-funded project, registering (hormones & contraceptives) across Africa and the Middle East.

Africa & Middle East Regional Regulatory Affairs Hub team lead-Strategist (Senior Manager), Pfizer Biopharmaceuticals Group, Cairo, Egypt, 12/01/18, 12/01/21,

• Played a key role in managing regulatory submissions, including the preparation and review of dossiers, to support product registration and approval processes.,
• Assessed regional regulatory requirements and ensured product compliance through effective coordination with internal departments and external partners.,
• Collaborate with cross-functional teams to provide regulatory input during product development, ensuring alignment with global regulatory strategies.,
• Conducted regulatory risk assessments and developed strategies to mitigate potential compliance issues, resulting in streamlined approval processes.,
• Contributed to developing and maintaining regulatory policies, procedures, and systems to ensure quality and compliance standards are maintained.,
• Prepared and delivered training sessions on regulatory guidelines and requirements to enhance regulatory awareness and knowledge within the organisation
• AFME LCM Regional Regulatory Affairs Senior Manager (Strategist) HUB team lead – Middle East, Pfizer Pharmaceuticals, Cairo, Egypt, 05/01/17, 11/01/18