Regulatory Project Manager & Ass. Regulatory Project Director
- Experience Level
- Experienced (non-manager)
Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functional and global? At AstraZeneca, we work at the cutting edge of science to develop the ground-breaking medicines of the future - here we do things that have never been done before. Does this match your skills and ambitions for the future? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic diseases!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. In our science-led enterprise, there are new, complex and first-in-class products to get to market. We drive fast approvals to play an instrumental role in achieving our aim of getting the right medicines to the right patients, faster than ever before. It's meaningful to be part of AstraZeneca's growth and deliver life-changing medicines to patients in areas of unmet medical needs.
We are now offering exciting opportunities for talented and highly motivated individuals to join our Regulatory Project Management team within the therapeutic areas Cardiovascular, Renal and Metabolism (CVRM) as Regulatory Project Managers (RPM) / Associate Regulatory Project Directors (ARPD).
These roles are based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden.
Our culture at AstraZeneca
Our advanced approach to Regulatory means we are leading the field. We are integrated in the drug development teams to influence early on and continue to add value throughout. Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology. We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives.
We're proud of our pipeline - it's not only changing the face of our industry for good and impacting the lives of patients, it's transforming the careers of our people. We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.
With us you will get the opportunity to work with a diverse portfolio in a global and innovative setting, such as digital science and novel therapeutic modalities, and at the same time contribute to our robust pipeline. And by doing so - gaining cutting edge Regulatory experience.
What you'll do
In your role as RPM/ARPD, you lead the end-to-end planning, coordination and execution of assigned regulatory procedures and submissions. You contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
The RPM/ARPD works in cross functional teams, with all phases of drug development across geographic region and are accountable for end to end regulatory project delivery and process improvements in line with business priorities.
Your main accountabilities/responsibilities:
- Lead and/or contribute to the planning, preparation and delivery of submissions of varying complexity throughout the product's life cycle from either a global and/or regional perspective.
- Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g. response documents, study protocols, Periodic Safety Reports
- Analysis of regulatory procedures and special designations used during development, authorizations and extensions of a medicinal product
- Lead multi-disciplinary project teams
- Identify regulatory risks and propose mitigations to appropriate member of cross functional teams.
- Support operational and compliance activities for assigned regulatory tasks
- Relevant University Degree in Science or related field
- Minimum 2 years regulatory experience within the biopharmaceutical industry or at a health authority. To qualify for the ARPD position, 4 years' experience of Regulatory Affairs for Medicinal Products in EU, US or other regions.
- Drug development knowledge
- Strong project management skills
- Excellent written and verbal communication skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Cultural awareness in a global company
- Proficiency with common project management and document management tools
- Ability to work independently and well as part of a team
- Ability to analyze problems and recommend actions
- Scientific knowledge in level to understand regulatory issues and facilitate scientific discussions
- Knowledge of the Cardiovascular, Renal and Metabolism therapy area
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! Welcome with your application (CV and cover letter) no later than March 7th, 2021.
We will review the applications continuously so please apply as soon as possible.