AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases.

We are happy to announce a role of Regulatory Project Manager at our Warsaw Site.

The Regulatory Project Manager (RPM) plans, prepares and delivers Clinical Trial Application (CTA) related regulatory documents to Health Authorities and/or Marketing Companies. The CTA RPM position sits within the Regulatory Project Management team within Oncology Regulatory Science and Strategy, which is part of Oncology R&D. The Oncology Regulatory Project Management team is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management, and strong leadership within the Oncology area.

We are now recruiting for a temporary CTA RPM position. We expect you to have experience from working in Regulatory Affairs, or elsewhere in the Pharmaceutical industry.

Responsibilities will include, but will not be limited to:

• Planning, preparing, handling, distributing and submitting regulatory documents to Health Authorities and/or Marketing Companies, globally, in support of clinical trials.
• Providing regulatory expertise on clinical trial related submissions to cross functional teams
• Monitoring, interpreting and validating current and changing regulatory legislation in relation to clinical trials and sharing potential impact these activities may have on the product development program.
• Performing regulatory review of clinical trial related documents
• Document management including updating and tracking study specific regulatory files and systems according to established AZ procedures and regulatory requirements
• Ensuring that all work is performed in accordance with established procedures and regulatory requirements
• Contributing to improvement of internal processes.

Requirements

• University Degree in Science or related discipline
• Relevant regulatory experience
• Excellent written and verbal communication skills
• Proficient verbal and written English
• Project Management experience
• Demonstrated good organization and time management skills and ability to manage tight timelines when required
• Ability to work in teams and collaborate closely with other functions
• Proficiency in various computer applications and the ability to quickly gain knowledge of, and operate in, internal databases
• Knowledge of new and developing regulatory and pharmacovigilance expectations

At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. We offer an attractive salary, a comprehensive employee benefits package and many opportunities to grow and develop within our global structure. Apply today and find out more.

Date Posted

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.