Regulatory Affairs Sr. Specialist NEMAG

Play a key role in bringing innovative medicines to patients. Join AstraZenecas Regulatory Affairs team and help navigate the regulatory pathway that supports the development approval and lifecycle management of impactful therapies.

ABOUT ASTRAZENECA

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.

Join a high-performing team empowered to cut through the noise and drive real change. Our agility and pace coupled with scientific focus powers us to spot opportunities in the market that keep us moving forward and into new spaces.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

ABOUT THE ROLE

Job Purpose:

As a Regulatory Affairs Senior Specialist you will be responsible for supporting the development and execution of global regulatory strategies to ensure timely approval and lifecycle management of AstraZenecas products. This role collaborates cross-functionally with clinical medical and commercial teams to ensure regulatory compliance while enabling efficient delivery of innovative medicines to patients.

Key Responsibilities:

• Support the preparation and submission of regulatory dossiers to the health authorities.
• Contribute to the development and implementation of regulatory strategies across product registrations & lifecycles for NEMAG markets mainly Iraq & Palestine.
• Ensure regulatory submissions comply with regional and international guidelines and standards.
• Coordinate with cross-functional teams including clinical development safety and quality.
• Maintain accurate regulatory documentation and submission records.
• Track regulatory commitments and support responses to health authority queries.
• Monitor evolving regulatory requirements and communicate potential impacts to stakeholders.
• Assist with new products & manufacturing sites registration & lifecycle management activities including variations renewals & label updates.
• Support preparation for regulatory meetings and health authority interactions.
• Contribute to continuous improvement initiatives within the Regulatory Affairs function.

Job Requirements:

Essential Criteria:

• Bachelors degree in pharmacy or any other scientific discipline.
• A minimum of 3 years of experience in Regulatory Affairs in a multinational pharmaceutical company.
• Proficiency in Arabic and English language is a must.
• Strong communication presentation and negotiation with the ability to convey complex information clearly and inspire cross-functional collaboration.
• Proficiency in Microsoft Office.
• Regulatory fundamentals knowledge.
• Flexible for travel upon business need.

Preferred Criteria:

• Regional Regulatory Affairs experience (mainly Iraq).
• Vault System knowledge.

Please note that this position is based in Cairo and is not open for relocation; only apply if you are located in or can easily access this location.

Where can I find out more

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Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.