Regulatory Affairs Director job opportunity at AstraZeneca.

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AstraZeneca Regulatory Affairs Director
Experience: 10-years
Pattern: full-time
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loacation Turkey - Istanbul, Turkey
loacation Turkey - Istan..........Turkey

Regulatory Director is responsible for developing and executing local regulatory strategies across assigned products and therapeutic areas, aiming for successful registrations and effective lifecycle management of unmet medical needs. The role leads local regulatory teams with a sense of urgency, provides strategic regulatory guidance to country-specific Program and Medicine Teams, and fosters effective, collaborative relationships with internal stakeholders and local regulatory authorities. Key Responsibilities Lead the development and implementation of global regulatory strategies for assigned portfolios or therapeutic areas, ensuring alignment with organizational goals and regulatory requirements. Comprehensive Regulatory Oversight: Provide expert strategic direction throughout the product lifecycle, from pre-approval through post-marketing activities, to support successful registrations and lifecycle management in accordance with corporate objectives. Oversee and support the preparation for regulatory agency meetings, direct submission strategies, and coordinate the development of key regulatory documents. Serve as the primary contact for health authorities and manage interactions with external stakeholders as needed. Contribute regulatory expertise to internal governance and advisory committees, addressing strategic, operational, and procedural regulatory matters. Collaborate closely with senior leadership and cross-functional teams—including Clinical, Commercial, and Medical Affairs—to provide regulatory insights at the portfolio level and inform broader drug development strategy. Maintain up-to-date knowledge of evolving regulatory landscapes, contribute to policy development, and support regulatory intelligence initiatives leveraging internal expertise. Exemplify high standards of ethical conduct, leadership, and transparency in all interactions with internal teams, health authorities, and external partners. Demonstrates expert knowledge of applicable GxPs and excels at identifying, sourcing, and interpreting complex regulatory requirements to ensure organizational compliance and informed decision-making Qualifications Bachelor’s degree (life sciences strongly preferred). Minimum of 10 years in pharmaceutical regulatory affairs, with a demonstrated track record in developing and executing regulatory strategies at the local level. In-depth understanding of drug development processes, local regulatory policies, and requirements. Proven ability to apply scientific and business judgment to regulatory decision-making. Documented achievements in obtaining product registrations and managing regulatory activities throughout various stages of development and commercialization within local markets. Skilled at handling complex regulatory challenges and managing multiple projects simultaneously under tight deadlines. Strong ability to foster relationships and collaborate effectively with local teams, internal stakeholders, and senior management across all organizational levels. Exceptional interpersonal abilities and proficiency in both written and verbal communication, tailored to local regulatory environments. Demonstrated expertise in identifying, assessing, and mitigating regulatory risks specific to local contexts. Advanced knowledge of emerging local regulations and guidance, including proficiency in relevant GxPs and the capability to source, interpret, and apply regulatory information to local requirements. Why AstraZeneca At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Where can I find out more? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/ Date Posted 14-Oca-2026 Closing Date 29-Eyl-2026 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.

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