Regulatory Project Manager and Ass. Regulatory Project Director

Are you experienced in regulatory affairs and have proven project management skills? Would you like to apply your expertise in a global company where we work together across boundaries to make the impossible a reality? Join us to be part of the development of innovative treatment of Respiratory and Immunology diseases.

At Late Respiratory & Immunology (Late R&I), we're driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with you. We need people like you who share our passion for science and determination to meet patients' needs around the world.

We are now looking for passionate colleagues to join our Regulatory Project Management team within R&I as Regulatory Project Managers (RPM) / Associate Regulatory Project Directors (ARPD).

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
* Analysis of regulatory procedures and special designations used during development, authorizations and extensions of a medicinal product
* 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.
* Lead multi-disciplinary project 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
* 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



Desirable for the role

* Scientific knowledge in level to understand regulatory issues and facilitate scientific discussions
* 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 August 7th, 2020!



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/



Why AstraZeneca?

AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that encourages innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity.

Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures, collaboration, openness and innovation. Therefore, we have created space for meetings, socializing and relaxation, where spontaneous meetings can give birth to new innovations. The unexpected ideas or thoughts that can come from a chat over something as simple as a cup of coffee or a stroll on our "walk and talk" meeting trail.