Global Regulatory Affairs Director

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About the role

Job Title: Global Regulatory Affairs Director  Location: Gaithersburg   At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.   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 head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.  Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.  Introduction to Role:   Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s) in product teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible for skill development, performance management, resource allocation. Accountabilities: · Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions · Provides strategic regulatory advice support for product developments regional therapy area · Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known · Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents · Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations · Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities · Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project · Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance · Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Essential Skills/Experience: • Bachelor’s Degree in Life Science or related discipline, • Advanced degree a plus. • 6 years experience of regulatory drug development, • Manufacture, commercialisation or equivalent. • Proven successful leadership and project management experience • Broad background of experience of working in several groups in regulatory affairs or experience at a health authority. • Knowledge of regulatory procedures and legislation f

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