Regulatory Affairs Group Director, Late CVRM Regulatory Affairs

Regulatory Affairs Group Director, Late CVRM Regulatory Affairs

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

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation –ultimately providingemployees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. 

Our dedication to sustainability is also central to our culture and part of what makes AstraZenecaa great placeto work. We know the health of people, theplanetand our business are interconnected, which is whywe’retaking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

About the Role

We are looking for a Regulatory Affairs Group Director (RAGD) for the Regulatory Affairs Management (RAM) group supporting the Cardiovascular,Renaland Metabolic Disease Areas. This group is part ofLateCVRM Regulatory.

AsRAGDyou will be part of the RAM leadership team, responsible for line management of 7-12 regulatory professional staff. You will contribute to the strategy,directionand efficient operation of the Regulatory TAorganizationas well as the RAM community. Provide regulatoryexpertiseand oversight to ensure high quality drug project operational delivery and efficiency by the group. You will also work on a drug project in a RAMrole ordrive continuous improvement or change projects.

Extensive regulatory affairs and drug development knowledgeiscritical, preferably with experience of leading major first wave submissions and leading complex regulatoryproceduresacross projects/products. You will alsopossessstrong leadership skills, haveexperience of developing teams, and excellent communication skills.

Other accountabilities will include:

• Provide leadership,coachingand line management for a group of Regulatory Affairs Managers based inWarsaw

• Ensure efficient, targeted recruitment for the group and lead talent and performance development activities

• Collaborate with the RAM leadership team to set the strategy for tactical delivery and efficiency for drug projects

• Lead development and continuous improvement of expert and/or process area and/or work on a drug project

• Establish and develop relationships with key partners, internally and externally

Essential Requirements:

• University Degree in Science or a related subject area

• Extensive regulatory affairs and drug development experience within the biopharmaceutical industry, or at a health authority

• Knowledge of regulatory requirements,proceduresand legislation for drug development, throughout the product lifecycle

• Proven successful leadership and project management experience

• Excellent collaboration,teamwork, oral and written communication skills

• Stronginfluencing andnegotiating skills.