Associate Regulatory Affairs Director Cardiovascular, Renal and Metabolism

Associate Regulatory Affairs Director – Cardiovascular, Renal and Metabolism 

Location: Warsaw, hybrid work (3 days per week from office)

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 Cardiovascular, Renal and Metabolism Therapy Area. 

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 looking for a member to join our Regulatory Affairs Management team within the Cardiovascular, Renal and Metabolism Therapy Area, in the role as  Associate Regulatory Affairs Director (ARAD). 

What you’ll do  

Working in the role as Associate Regulatory Affairs Director (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 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 

Requirements:

Minimum Requirements –Education and Experience:

• Relevant University Degree in Science or related discipline
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
• Thorough Knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Desirable:

• Previous experience working with Clinical Trial Applications 
• Leading major submissions or Health Authority interactions 

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

Onsite position 

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.