Roles within Regulatory Affairs

Do you have in depth knowledge within Regulatory Affairs and want to develop your skills within project management?

At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments of Cardiovascular, Renal and Metabolic (CVRM) diseases!

AstraZeneca's pipeline of innovative medicines is consistently growing within CVRM. Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.



The role

We are now seeking new members to join our Regulatory Affairs Management team within the CVRM therapeutic areas, in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD). These roles can be based in Gothenburg or in Södertälje, Sweden. With employees from more than 50 countries, our sites are a truly inspiring place to work.



What you'll do

Working in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD), you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions. With your knowledge, you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.



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



Do you have the essential qualifications for these roles?

To be successful in these roles, we believe that you have a University degree in science or a related field. A minimum of 2 years regulatory experience within the biopharmaceutical industry or at a health authority is needed to apply for the role as Regulatory Affairs Manager. To be considered for the more senior role as Associated Regulatory Affairs Director, 4 years' experience of Regulatory Affairs for Medicinal Products in EU, US or other regions is needed as well as proven leadership and project management skills. Both roles require drug development knowledge.

We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.

If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.



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 7 august, 2022.

NOTE - Due to our summer vacation period in Sweden during July-August, the screening process may take a bit longer than usual. Thanks for your understanding and we will get back to you as soon as possible when we are back at work. Interviews will be held mid-August.