Regulatory Operations Manager
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Regulatory Operations Manager (ROM) in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
Main Duties and Responsibilities
In this role, you will be responsible for end-to-end submission publishing, which includes planning, compiling, publishing, delivering and archiving of regulatory submissions in accordance with health authority standards and AstraZeneca procedures. You will provide support to project teams, external partners and stakeholders on topics related to document and submission publishing in accordance to the Operating Model.
- University degree or equivalent experience in life sciences or technical field
- Minimum 2 years hands-on experience with publishing eCTD submissions
- Demonstrated ability to work in accordance with processes
- Demonstrated ability to work collaboratively in a global team environment and to have good project management skills
- Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment
- Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications
- Excellent English written and verbal communication skills.
- Experience of system administration for validated applications within a regulated environment
- Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions
- Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox)
- Knowledge of AstraZeneca submission compilation, publishing, approval processes, tools and standards
- Ability to thrive in a rapid paced environment
- Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
- Good problem and conflict resolution skills.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.