Roles within Regulatory Affairs - Respiratory & Immunology

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 are driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with you. We need people who share our passion for science and determination to meet patients' needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative treatment of Respiratory and Immunology (R&I) diseases.

We are now looking for passionate colleagues to join our Regulatory Project Management team as Regulatory Project Managers (RPM) / Associate Regulatory Project Directors (ARPD). With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules.

The role is based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden.



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
* Lead multi-disciplinary project teams
* Support operational and compliance activities for assigned regulatory tasks
* Provide coaching, mentoring and knowledge sharing within the regulatory skill group
* Contribute to and lead process improvement
* Identify regulatory risks and propose mitigations to appropriate member of cross functional teams.



Essential for the role

* Relevant University Degree in Science or related field
* Minimum 2 years regulatory experience within the biopharmaceutical industry, or at a health authority, or other proven experience. The Level considered is based on the candidates experience.
* 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 as 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



Desirable for the role

* Knowledge of the R&I therapy area



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Welcome with your application no later than May 31st, 2021.

We will review the applications continuously so please apply as soon as possible.



Where can I find out more?

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html

Life in Gothenburg: https://www.movetogothenburg.com/

Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/