Regulatory Affairs Lead

This position will be located in Egypt or Jordan according to the selected candidate home country's nationality.

Introduction to role:

Are you ready to be part of the team of Regulatory affairs for Near East & Maghreb Countries markets? As the Regulatory Affairs Lead, you'll ensure AstraZeneca's "License to Operate" regulatory activities are met for all products, aligning with Near East & Maghreb Countries markets legislation and our code of "Good Regulatory Practice." You'll coordinate the regulatory team, offering scientific and regulatory knowledge while implementing standard methodologies. Set strategic directions and collaborate with senior cross-functional team members to impact the external regulatory environment and deliver business-critical regulatory needs. Take control of the registration process for specific products within a therapeutic area and obtain crucial marketing authorizations. Your role will be pivotal in ensuring regulatory compliance and maintaining ethical standards.

Accountabilities:

• Organize  regulatory plans for all products in Iran, Iraq & Palestine, implementing agreed regulatory strategies.
• Leading the policy shaping initiatives in the designated countries
• Support local distributor regulatory teams in registration and maintenance activities, ensuring compliance with local and global codes.
• Obtain regulatory approvals and maintain variation procedures effectively.
• Follow up on variations approval processes, anticipating questions from authorities.
• Answer health authority queries consistently and within time limits.
• Communicate variations and changes to regulatory authorities as required.
• Liaise closely with QA and other teams to ensure timely responses to queries.
• Update management with health authority changes affecting AZ products.
• Ensure effective documentation and archiving of submission and approval documents.
• Maintain regulatory databases and track submissions to satisfy audit requirements.
• Ensure the appropriate implementation and maintenance of regulatory tools
• Foster a culture of courageous leadership, creativity, and collaboration within the team.

Essential Skills/Experience:

• A bachelor's degree in pharmacy is required.
• 8-10 years of experience in Regulatory Affairs.
• 3-5 years of experience in Iraq and Iran.
• Leading policy shaping initiatives and advocacy plans.
• Proven experience in line management, staff development, and process management.
• Demonstrated strong leadership abilities, strategic thinking, business acumen, precision, and flexibility.
• Adherence to pharmaceutical industry ethics.
• Excellent command of the English language.
• Proficiency in Microsoft applications.
• Ability to travel.

Desirable Skills/Experience:

• Project management experience.
• Time management and planning skills.
• Excellent written and verbal communication skills.
• Strong interpersonal skills with a customer relationship focus.
• Uncompromising attention to detail and accuracy.
• Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational, and problem-solving skills.
• Ability to work independently in a high-pressure environment.

AstraZeneca offers a unique environment where high standards meet complex challenges. Here, you can make a significant impact by improving market operations and leaving your individual mark. As part of a responsible business with a strong sustainability agenda, you can influence the future beyond business projects. Our culture fosters learning and development, backed by strong leadership that encourages collaboration without fear of failure. Join us to embrace challenges in an open community that supports growth and innovation.

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 authorisation and employment eligibility verification requirements.