Regulatory Affairs Manager / Associate Regulatory Affairs Director

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 in the Vaccines and Immunology Therapies Areas.
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 Vaccines and Immunology Therapies Areas, in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD). These roles will be based at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is 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 of 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, a deeper understanding of Regulatory Affairs, proven leadership and project management skills are required. 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 us? Good, because we can’t wait to hear from you!