At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

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 Oncology Regulatory Affairs. The 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 permanent CTA RPM positions.

We expect you to have experience from working in Regulatory Affairs, or elsewhere in the Pharmaceutical industry.

Typical Accountabilities

Responsibilities include but are not 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
• Contribute to improvement of internal processes

Education, Qualifications, Skills and Experience

Essential:

• University Degree in Science or related discipline
• Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry e.g. CRO, Marketing Company, Health Authority, R&D or Operations
• 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

Desirable:

• Knowledge of new and developing regulatory and pharmacovigilance expectations

Next step - Apply today!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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.