Regulatory Affairs Manager / Associate Regulatory Affairs Director

Do you have experience in Regulatory Affairs and a desire to grow your project leadership capabilities?

At AstraZeneca, you'll join a collaborative environment where Regulatory Affairs plays a key role throughout the entire drug development lifecycle - from early clinical trials to global marketing authorization. Here, you'll 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 cross-functional teams across disciplines and geographies to ensure that regulatory procedures progress smoothly through approval.

What you'll 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 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 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 medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.