Regulatory Affairs Manager Associate Regulatory Affairs Director Cardiovascular, Renal and Metabolism
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Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Do you have experience in Regulatory Affairs and a desire to grow your project leadership capabilities
At AstraZeneca youll join a collaborative environment where Regulatory Affairs plays a key role throughout the entire drug development lifecyclefrom early clinical trials to global marketing authorisation. Here youll contribute to submissions that have real impact on patients living with Cardiovascular Renal and Metabolic (CVRM) diseases.
About the role
We are looking for new colleagues to join our CVRM Regulatory Affairs Management team in Gothenburg Sweden. Based on your experience you may join us as either a Regulatory Affairs Manager (RAM) or an Associate Regulatory Affairs Director (ARAD).
In these roles you will contribute to global and regional regulatory strategies identify risks and opportunities and lead regulatory submissions of varying complexity. You will work closely with crossfunctional teams across disciplines and geographies to ensure that regulatory procedures progress smoothly through approval.
What youll do
In the RAM/ARAD roles you will:
Lead and/or contribute to the planning preparation and delivery of submissions of varying complexity throughout the products 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 requirements
University degree in a scientific or related discipline.
RAM: Minimum 2 years of Regulatory Affairs experience in the biopharmaceutical industry or a Health Authority.
ARAD: 4 years of global/regional Regulatory Affairs experience (EU US or other regions) including demonstrated project leadership.
For both roles:
Strong understanding of the drug development process.
Solid project management and leadership capabilities.
Excellent written and verbal communication skills.
Experience leading multi-disciplinary teams is an advantage.
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Ready to make a difference
If this sounds like your next step wed love to hear from you. Please submit your CV and cover letter no later than 15 February 2026.
Date Posted
02-Feb-2026Closing Date
15-Feb-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
