Director Global Regulatory Policy

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to role

The Director Global Regulatory Policy is responsible for driving globally impacting regulatory policy development and advocacy in cooperation with regional and functional experts. The Director provides a broad strategic view for regulatory policy issues based on in-depth knowledge of the internal and external regulatory environment.  The Director will develop and help to implement aligned company policy positions and facilitate stakeholder interactions, leading to more impactful external engagements for AZ’s disease areas of interest. 

The Director will be a major participant articulating AZ’s consolidated view on key regulatory guidance and regulations. This includes maintaining and developing key health authority relationships and being able to influence proposed rules and regulations that specifically impact AZ and ultimately the pharmaceutical industry. The incumbent can also lead implementation of changes to strategy and processes due to significant regulatory environment changes (new legislation/guidance etc) and can lead AZ’s response to key regulatory policy topics on a Global basis.

The Director will have a major role interacting with other parts of the AZ organization that are influencing policy and legislation. 

The Director attends relevant external meetings or conferences of value to the business, and contributes to the overall strategy, direction and efficient operation of the function. 

Accountabilities

• Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Senior Directors/Group Head.

• Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders, including the Regulatory TAs, Commercial, MC regulatory, R&D and CMO functions.

• Support preparation of regulatory policy documents, including position statements, reports, draft papers and presentation materials.

• Represent AZ Regulatory Affairs on selected external Trade Association committees to ensure AZ Regulatory views on key issues are known

• Attend relevant external meetings/conferences to obtain relevant intelligence of value to the business and communicate effectively.

• May represent AZ in external benchmarking on advocacy business practices.

• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

• Contribute to the strategy, direction and efficient operation of the immediate team and function.

Essential Skills/Experience

• Understands the role of external policy and advocacy and connections to business goals.

• Demonstrated expertise in Regulatory policy-related matters, through Health Authority or Industry experience.

• Working knowledge of AstraZeneca focused disease areas.

• Thorough understanding and application of the Drug Development and associated regulatory processes.

• Collaborative and able to build consensus with peers and leadership (ability to influence upwards).

• Strong oral and written communication skills.

• Experience in knowledge management and digital information management.

Desirable Skills/Experience

• Problem-solving skills.

• Focus on delivery and results.

• Excellent strategic influencing and negotiation.

• Experienced Regulatory Professional with a degree in a scientific discipline, typically pharmacy or a biological science.

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Our inclusive, diverse, and bold environment empowers us to be the best we can be. We thrive on collaboration, sharing knowledge, and setting each other up for success. By delivering rapid and global approvals, we transform breakthrough science into tangible value for patients.

Join us in making a difference – apply today!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.